Product Code: HWC FDA class 2 21 CFR 888.3040

Screw, Fixation, Bone

Orthopedic

A bone fixation screw is a threaded metallic implant used in orthopedic surgery to stabilize bone fractures, attach plates or other hardware to bone, or secure bone grafts and prosthetic components. It is classified as an FDA Class 2 device under 21 CFR 888.3040, indicating moderate risk and requiring 510(k) premarket clearance. Product code HWC falls under the Orthopedic medical specialty. This device is an implant.

View on FDA

510(k)s

1041

FEI Numbers

653

Registration Numbers

653

Unique Applicants

435

Years Active

Basic Information

Product Code: HWC
Device Class: FDA class 2
Regulation Number: 888.3040
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 1041 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250251	Eleganz Fusion Screw System (Fusion Screw System)	Jun 13, 2025	Substantially Equivalent	Dev4
K243943	TriMed® Compression Screws	Apr 10, 2025	Substantially Equivalent	TriMed, Inc.
K250613	SnapHammer Hammertoe Correction System	Apr 02, 2025	Substantially Equivalent	Nvision Biomedical Technologies Inc
K250304	TITANEX Screw Systems	Mar 05, 2025	Substantially Equivalent	Vilex LLC
K242896	Caliber Intramedullary Fixation System	Feb 05, 2025	Substantially Equivalent	Nvision Biomedical Technologies
K242442	Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw	Jan 31, 2025	Substantially Equivalent	Innovate Orthopaedics Ltd
K243195	Arthrex SS VAL and VAL KreuLock Compression Screw System	Jan 10, 2025	Substantially Equivalent	Arthrex, Inc.
K242348	Locking Screw,CoCrMo	Dec 04, 2024	Substantially Equivalent	Double Medical Technology Inc.
K233567	OsteoCoil Nitinol Compression System (Multiple Component PNs)	Nov 22, 2024	Substantially Equivalent	Flower Orthopedics Corporation DBA Conventus Flower Ortho
K240175	Tigon Medical Fractures, Instability, and Reconstruction (FIRE)	Oct 29, 2024	Substantially Equivalent	Tigon Medical
K242691	OsteoCentric Technologies Cannulated Fasteners and Nuts	Oct 09, 2024	Substantially Equivalent	OsteoCentric Technologies
K242671	Treace Medical Concepts (TMC) Screw Fixation System	Oct 04, 2024	Substantially Equivalent	Treace Medical Concepts Inc.
K241592	Arthrex VAL and VAL KreuLock Compression Screw System	Aug 31, 2024	Substantially Equivalent	Arthrex, Inc.
K241359	Medline UNITE® MIS Foot Recon Screw System	Aug 02, 2024	Substantially Equivalent	Medline Industries, LP
K241277	OSSIOfiber® Threaded Trimmable Fixation Nail	Jul 03, 2024	Substantially Equivalent	OSSIO Ltd.
K240815	Arthrex Cannulated Screw System	Jun 13, 2024	Substantially Equivalent	Arthrex Inc.
K233008	Cannulated Headless Bone Screws	Jun 05, 2024	Substantially Equivalent	aap Implantate AG
K240530	DynaNail Mini Tapered Hybrid	Mar 21, 2024	Substantially Equivalent	MedShape, Inc.
K233912	ARIX Cannulated Screw System	Mar 11, 2024	Substantially Equivalent	Jeil Medical Corporation
K233198	OSSIOfiber® Threaded Trimmable Fixation Nails	Mar 08, 2024	Substantially Equivalent	OSSIO Ltd.
K231453	SnapHammer Hammertoe Correction System	Feb 16, 2024	Substantially Equivalent	Nvision Biomedical Technologies, Inc
K234040	TriMed Threaded Intramedullary Nail System	Jan 18, 2024	Substantially Equivalent	TriMed, INC
K231860	TDM Screw System	Jan 18, 2024	Substantially Equivalent	TDM Co., Ltd.
K230507	Zimed Distal Medial Tibial Plate and Screw System	Jan 04, 2024	Substantially Equivalent	Zimed Medikal
K233396	Cannulated Screw System	Dec 21, 2023	Substantially Equivalent	Smith & Nephew Inc.
K232251	APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension	Nov 03, 2023	Substantially Equivalent	Medartis AG
K231231	MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices	Oct 12, 2023	Substantially Equivalent	Paragon 28 Inc.
K231649	Intraosseous Fusion Device System	Sep 29, 2023	Substantially Equivalent	Auxano Medical LLC
K230946	Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L	Sep 15, 2023	Substantially Equivalent	Trax Surgical
K231504	TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System	Sep 11, 2023	Substantially Equivalent	Vilex LLC
K231819	Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw	Sep 05, 2023	Substantially Equivalent	Innovate Orthopaedics Limited
K223468	Nexis® compressive screws	Aug 30, 2023	Substantially Equivalent	Novastep
K231236	IBS-B MIS Beveled Screw System	Jul 27, 2023	Substantially Equivalent	In2Bones USA, LLC
K230945	Forma Medical Headless Compression Screw	Jul 18, 2023	Substantially Equivalent	Forma Medical, Inc.
K230595	OsteoCentric ACL Fixation System	Jun 29, 2023	Substantially Equivalent	OsteoCentric Technologies
K230867	Bone Bolt System	Jun 26, 2023	Substantially Equivalent	University of Utah, Department of Orthopaedics
K230397	Cut Screw - Percutaneous Compression Screw	Jun 12, 2023	Substantially Equivalent	GM Dos Reis Industria e Comercio Ltda
K230744	Acumed Acutrak 3 Headless Compression Screw System	Jun 09, 2023	Substantially Equivalent	Acumed LLC
K230908	Hand Trauma Threaded Nail System	Apr 28, 2023	Substantially Equivalent	Skeletal Dynamics, Inc.
K230053	SimpliFix Hip System	Apr 19, 2023	Substantially Equivalent	Stabiliz Orthopaedics Inc.
K230749	TriMed Threaded Intramedullary Nail System	Apr 17, 2023	Substantially Equivalent	TriMed, Inc.
K223392	REVCON (TM) Screw System	Feb 28, 2023	Substantially Equivalent	Voom Medical Devices, Inc.
K221645	PROstep(TM) MIS 5mm Chamfer Screw System	Feb 17, 2023	Substantially Equivalent	Wright Medical Technology
K230118	Bony Trauma Extremity System (BTES) Screw Range, NX Nail	Feb 16, 2023	Substantially Equivalent	Field Orthopaedics Pty Ltd
K223761	OIC Intramedullary Screw System	Feb 13, 2023	Substantially Equivalent	Orthopaedic Implant Company
K223847	CREED Cannulated Screws	Jan 25, 2023	Substantially Equivalent	GLW, Inc.
K222799	Haymaker® Screw System	Jan 10, 2023	Substantially Equivalent	OrthoCircle Spine d.b.a. OC Medical Devices
K221090	Metal Cannulated Screw	Jan 10, 2023	Substantially Equivalent	Double Medical Technology Inc.
K221333	Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional	Dec 29, 2022	Substantially Equivalent	Acumed LLC
K221193	OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm	Dec 23, 2022	Substantially Equivalent	OSSIO Ltd.
K223184	Phantom Metatarsal Shortening System	Dec 16, 2022	Substantially Equivalent	Paragon 28, Inc.
K222820	BRM TOOL Screws, BIOPLAN Subtalar Implant	Dec 16, 2022	Substantially Equivalent	BRM Extremities
K221342	REDEMPTION Beaming System	Dec 13, 2022	Substantially Equivalent	Vilex, LLC
K220921	Metal Bone Screw	Dec 12, 2022	Substantially Equivalent	Double Medical Technology Inc.
K222967	Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws	Nov 23, 2022	Substantially Equivalent	Avanti Orthopaedics, Inc.
K222564	Treace Medical Concepts (TMC) Hammertoe Fixation System	Nov 15, 2022	Substantially Equivalent	Treace Medical Concepts, Inc.
K221610	Nextra CH Cannulated Hammertoe System	Nov 04, 2022	Substantially Equivalent	Nextremity Solutions, Inc.
K222505	CurvaFix IM System	Oct 27, 2022	Substantially Equivalent	CurvaFix, Inc.
K220359	Tandry Compression Screw System	Sep 20, 2022	Substantially Equivalent	Microware Precision Co., Ltd.
K220839	Arthrex Compression FT Pins	Sep 19, 2022	Substantially Equivalent	Arthrex Inc.
K222409	CAPTIVATE® Compression Screws	Sep 08, 2022	Substantially Equivalent	Globus Medical, Inc.
K213614	Cannulated Screws	Aug 03, 2022	Substantially Equivalent	Maxxion Medical, LLC
K220319	Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System	Jun 10, 2022	Substantially Equivalent	Stryker GmbH
K220723	Hand Trauma Screw System	May 12, 2022	Substantially Equivalent	Skeletal Dynamics, Inc.
K220892	ExsoMed INnate NanoTM Lag Screw System	Apr 27, 2022	Substantially Equivalent	ExsoMed Corp.
K210146	Cannulated Compression Device System	Apr 13, 2022	Substantially Equivalent	Orthopedic Designs North America, Inc.
K220511	Medline UNITE IM Fibula Implant	Mar 22, 2022	Substantially Equivalent	Medline Industries, LP
K212755	SIGNUS SACRONAIL® Transsacral Stabilization System	Mar 10, 2022	Substantially Equivalent	SIGNUS Medizintechnik GmbH
K203335	MectaScrew Extension	Feb 03, 2022	Substantially Equivalent	Medacta International SA
K211628	MIS Precision Chevron Bunion System	Jan 31, 2022	Substantially Equivalent	RELJA Innovations, LLC
K213572	JuniOrtho Plating System	Jan 18, 2022	Substantially Equivalent	Orthofix Srl
K203773	BRM TOOL Screws	Jan 14, 2022	Substantially Equivalent	BRM Extremities Srl
K213199	Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System	Jan 11, 2022	Substantially Equivalent	Stryker GmbH
K203595	DynaFuse Fixation System	Jan 04, 2022	Substantially Equivalent	MedShape, Inc.
K212547	Quick-Start Screws	Dec 30, 2021	Substantially Equivalent	Innovate Orthopaedics Limited
K211770	R3ACT Stabilization System	Dec 25, 2021	Substantially Equivalent	Paragon 28, Inc.
K213596	OSSIOfiber Compression Screw, 3.5mm	Dec 21, 2021	Substantially Equivalent	OSSIO Ltd.
K213301	InCore Subtalar System	Dec 21, 2021	Substantially Equivalent	Nextremity Solutions, Inc.
K213530	Nextra CH Cannulated Hammertoe System	Dec 09, 2021	Substantially Equivalent	Nextremity Solutions, Inc.
K213421	Vector® Hammertoe Correction System	Nov 19, 2021	Substantially Equivalent	Nvision Biomedical Technologies, Inc
K212996	Sterile PHALINX Hammertoe System	Nov 16, 2021	Substantially Equivalent	Wright Medical Technology, Inc.
K202326	BESPA Charcot System	Nov 09, 2021	Substantially Equivalent	Bespa Global, LLC
K213036	Treace Medical Concepts (TMC) Screw Fixation System	Oct 21, 2021	Substantially Equivalent	Treace Medical Concepts, Inc.
K210490	ChM 4.5mm Cortical screws	Oct 05, 2021	Substantially Equivalent	ChM sp. z o.o.
K211996	Nexta PEEK Hammertoe Correction System	Sep 23, 2021	Substantially Equivalent	Nextremity Solutions, Inc.
K210792	Auxein Nailing System	Aug 25, 2021	Substantially Equivalent	Auxein Medical Private Limited
K203029	Auxilock Titanium Interference Screw	Aug 20, 2021	Substantially Equivalent	Auxein Medical Private Limited
K211783	TriMed Threaded Intramedullary Nail System	Aug 06, 2021	Substantially Equivalent	TriMed, Inc.
K211435	PAO Cortical Screw	Aug 06, 2021	Substantially Equivalent	Medacta International SA
K211290	Cannulated Fasteners and Nuts	Aug 03, 2021	Substantially Equivalent	OsteoCentric Technologies
K210159	IntraLock System	Jul 23, 2021	Substantially Equivalent	Fusion Orthopedics, LLC
K211944	Medline UNITE® Digital Fusion Screw System	Jul 22, 2021	Substantially Equivalent	Medline Industries, Inc.
K210994	Arthrex Beveled FT Screws	Jun 01, 2021	Substantially Equivalent	Arthrex Inc.
K211261	Axis Charcot Fixation System	May 28, 2021	Substantially Equivalent	Extremity Medical, LLC.
K203228	DART-FIRE EDGE Cannulated Screw System	May 11, 2021	Substantially Equivalent	Wright Medical
K210754	Cannulated Fasteners and Nuts	Apr 14, 2021	Substantially Equivalent	OsteoCentric Technologies
K210268	LTJ Screws and Washer	Feb 26, 2021	Substantially Equivalent	AzurMeds Inc.
K203381	Dynanail Mini Hybrid	Jan 15, 2021	Substantially Equivalent	MedShape Inc
K203105	Inion CompressOn Screw	Jan 13, 2021	Substantially Equivalent	Inion Oy
K193497	Fixone Biocomposite Interference Screw	Jan 05, 2021	Substantially Equivalent	AJU Pharm Co., Ltd.
K203239	Arthrex Low Profile Screws	Dec 30, 2020	Substantially Equivalent	Arthrex Inc.
K203467	WishBone Medical Plate and Screw System	Dec 23, 2020	Substantially Equivalent	WishBone Medical, Inc.
K200291	CREED Cannulated Screws	Dec 16, 2020	Substantially Equivalent	GLW Medical Inc
K203011	Monster Screw System	Nov 13, 2020	Substantially Equivalent	Paragon 28, Inc.
K202589	APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System	Nov 06, 2020	Substantially Equivalent	Medartis AG
K202817	GEO Bone Screw System	Oct 22, 2020	Substantially Equivalent	Gramercy Extremity Orthopedics, LLC
K202680	OsteoMed ExtremiFix Mini & Small Cannulated Screw System	Oct 15, 2020	Substantially Equivalent	OsteoMed LLC
K202569	Responsive Arthroscopy Interference Screw System	Sep 23, 2020	Substantially Equivalent	Responsive Arthroscopy LLC
K200987	LTJ Screws and Washer	Sep 22, 2020	Substantially Equivalent	AzurMeds inc.
K201850	Vector Hammertoe Correction System	Aug 04, 2020	Substantially Equivalent	Nvision Biomedical Technologies, Inc
K193660	OSSIOfiber Compression Screws	Jul 30, 2020	Substantially Equivalent	Ossio Ltd.
K201662	REDUCT® Headless Compression Screw System	Jul 16, 2020	Substantially Equivalent	Skeletal Dynamics, Inc.
K201556	Intraosseous Fixation System	Jul 08, 2020	Substantially Equivalent	Extremity Medical, LLC.
K200840	DuoHex CH Cannulated Hammertoe System	Jun 26, 2020	Substantially Equivalent	Nextremity Solutions, Inc.
K200226	RetroFix	Jun 26, 2020	Substantially Equivalent	Retrofix Screws, LLC
K201430	InFrame Cannulated Fixation System	Jun 20, 2020	Substantially Equivalent	ExsoMed, Corp.
K201319	Medline UNITE Jones Fracture Screw System	Jun 17, 2020	Substantially Equivalent	Medline Industires, Inc.
K200124	InCore MPJ System	May 13, 2020	Substantially Equivalent	Nextremity Solutions, Inc.
K200914	Healix Compression Screw System	May 05, 2020	Substantially Equivalent	Nvision Biomedical Technologies, Inc
K200259	Headless Compression Screw System	May 04, 2020	Substantially Equivalent	OsteoCentric Extremities, LLC
K191995	S4 Screw System	Apr 18, 2020	Substantially Equivalent	Subchondral Solutions, Inc.
K193366	T2 ICF	Mar 20, 2020	Substantially Equivalent	Stryker GmbH
K193491	restor3d Metallic Interference Screw	Mar 19, 2020	Substantially Equivalent	restor3D
K192096	Omnia Medical Trauma Screws	Feb 27, 2020	Substantially Equivalent	Omnia Medical, LLC
K193451	Titanium Interference Screws	Feb 24, 2020	Substantially Equivalent	Biomet Inc.
K193156	Arthrex Mini Comprehensive Fixation System - 1.0mm Screws	Feb 10, 2020	Substantially Equivalent	Arthrex Inc.
K192975	Tyber Medical Trauma Screws	Jan 09, 2020	Substantially Equivalent	Tyber Medical LLC
K192974	Tyber Medical Trauma Screw	Jan 08, 2020	Substantially Equivalent	Tyber Medical LLC
K192578	InCore TMT System	Dec 31, 2019	Substantially Equivalent	Nextremity Solutions, Inc.
K192745	DePuy Synthes Trauma Screws	Nov 26, 2019	Substantially Equivalent	Synthes (USA) Products LLC / DePuy Orthopaedics Inc
K192417	ARIX Cannulated Screw System	Nov 26, 2019	Substantially Equivalent	Jeil Medical Corporation
K191651	Arthrex Nano SwiveLock Suture Anchor	Nov 06, 2019	Substantially Equivalent	Arthrex Inc.
K190921	Arthrex Low Profile Screws	Oct 30, 2019	Substantially Equivalent	Arthrex Inc.
K191771	SECURE Screw	Oct 16, 2019	Substantially Equivalent	A.M. Surgical, Inc.
K190830	TDM Screw Systems	Sep 13, 2019	Substantially Equivalent	TDM Co. Ltd.
K191424	Interphalangeal Joint Fusion Device Range	Aug 28, 2019	Substantially Equivalent	Neosteo
K191342	CrossRoads Screw System	Aug 19, 2019	Substantially Equivalent	CrossRoads Extemity Systems, LLC
K190970	PROSTEP TBI (Tailors Bunion Implant) System	Aug 13, 2019	Substantially Equivalent	Wright Medical Technology, Inc.
K191289	Bone Screw Line Addition	Jul 29, 2019	Substantially Equivalent	Vilex in Tennessee, Inc
K191817	ActivOrtho Continuous Compression Screw System	Jul 26, 2019	Substantially Equivalent	ActivOrtho, Inc.
K190324	OrthoPediatrics Cannulated Screw System	Jul 05, 2019	Substantially Equivalent	Orthopediatrics, Corp
K183363	Treace Medical Concepts (TMC) Snap-Off Screw System	Jun 13, 2019	Substantially Equivalent	Treace Medical Concepts, Inc.
K183104	Mini Cannulated Headed and Headless Screw Set	Jun 10, 2019	Substantially Equivalent	Stryker GmbH
K190231	InCore® Lapidus Sterile Kits	May 24, 2019	Substantially Equivalent	Nextremity Solutions, Inc.
K182342	IntraLock Lapidus System	May 21, 2019	Substantially Equivalent	Fusion Orthopedics, LLC
K183395	Arthrex 2.5 mm Tenodesis Screw	Apr 17, 2019	Substantially Equivalent	Arthrex Inc.
K190586	Monster® Screw System	Apr 03, 2019	Substantially Equivalent	Paragon 28, Inc.
K183628	Arthrex TensionLoc System	Mar 26, 2019	Substantially Equivalent	Arthrex Inc.
K190430	OsteoCentric Bone Plate and Screw System	Mar 22, 2019	Substantially Equivalent	OsteoCentric Trauma
K183026	Wright Jones Fracture System	Mar 13, 2019	Substantially Equivalent	Wright Medical Technology, Inc.
K183603	INnate Cannulated Screw System	Mar 12, 2019	Substantially Equivalent	Exsomed Corporation
K181610	ActivOrtho Nitinol Compression Screw System	Mar 12, 2019	Substantially Equivalent	ActivOrtho, Inc
K180050	CurvaFix Intramedullary Rodscrew System	Mar 01, 2019	Substantially Equivalent	CurvaFix, Inc.
K183055	Vector Hammertoe Correction System	Feb 19, 2019	Substantially Equivalent	Nvision Biomedical Technologies, LLC
K182677	DynaNail Mini	Feb 14, 2019	Substantially Equivalent	Medshape, Inc.
K190035	Biomet Headless Compression and Twist-Off Screws	Feb 07, 2019	Substantially Equivalent	Biomet Inc
K182955	EZStart Interference Screw	Jan 22, 2019	Substantially Equivalent	ConMed Corporation
K181377	PROSTEP MICA Screw System	Jan 11, 2019	Substantially Equivalent	Wright Medical Technology, Inc.
K182989	AURORA Screw System	Dec 18, 2018	Substantially Equivalent	MiRus, LLC
K182361	Arthrex Compression FT Screws	Dec 18, 2018	Substantially Equivalent	Arthrex Inc.
K180670	ICONN Campbell Interference Screw	Dec 07, 2018	Substantially Equivalent	ICONN Orthopedics, LLC
K182949	Healix Compression Screw System	Dec 04, 2018	Substantially Equivalent	Nvision Biomedical Technologies, LLC
K182684	HammerTechTM Fixation System	Nov 23, 2018	Substantially Equivalent	Fusion Orthopedics, LLC
K180573	Responsive Arthroscopy Interference Screw System	Nov 23, 2018	Substantially Equivalent	Responsive Arthroscopy LLC
K180541	DePuy Synthes 2.0 mm Quick Insertion Screws	Nov 21, 2018	Substantially Equivalent	Synthes USA Products, LLC
K181898	Two-Step Implant System	Oct 26, 2018	Substantially Equivalent	Trilliant Surgical
K182148	SILVERBACK Gorilla Plating System	Sep 07, 2018	Substantially Equivalent	Paragon 28, Inc.
K180348	Field Orthopaedics Micro Screw System	Jul 17, 2018	Substantially Equivalent	Field Orthopaedics Pty. Ltd.
K173556	Injection Screw	Jul 13, 2018	Substantially Equivalent	Biedermann Medtech, Inc.
K180024	SALVATION Midfoot Nail	Jul 11, 2018	Substantially Equivalent	Wright Medical Technology, Inc.
K180377	Fracture and Correction System	Jun 20, 2018	Substantially Equivalent	In2Bones USA, LLC
K180500	VariAx 2 System	Jun 04, 2018	Substantially Equivalent	Stryker GmbH
K180932	Diamond Orthopedic Bone Fixation Screws and Pins	May 09, 2018	Substantially Equivalent	Diamond Orthopedic, LLC
K180257	InCore® Lapidus System	Apr 25, 2018	Substantially Equivalent	Nextremity Solutions, Inc.
K180753	SafetyFix EasyOut System	Apr 20, 2018	Substantially Equivalent	SafetyFix Medical Technologies, Inc.
K173710	MotoBAND CP Implant System	Feb 12, 2018	Substantially Equivalent	CrossRoads Extremity Systems, LLC
K172698	G-Beam Fusion Beaming System	Feb 07, 2018	Substantially Equivalent	Orthofix Srl
K171628	HBS2 Headless Bone Screw	Jan 12, 2018	Substantially Equivalent	Stuckenbrock Medizintechnik GmbH
K172383	Arthrosurface Bone Screws	Dec 22, 2017	Substantially Equivalent	Arthrosurface, Inc.
K173286	Cannulated Screw Internal Fixation System	Dec 14, 2017	Substantially Equivalent	Life Spine Inc.
K170688	PITStop® implant	Nov 28, 2017	Substantially Equivalent	In2Bones SAS
K173135	VariAx 2 System	Nov 27, 2017	Substantially Equivalent	Stryker GmbH
K172617	Treace Medical Concepts (TMC) Compression Screw System	Oct 25, 2017	Substantially Equivalent	Treace Medical Concepts, Inc.
K172213	MECRON Cannulated Screw System	Oct 23, 2017	Substantially Equivalent	Merete GmbH
K170056	IRENE Cannulated Screw System	Oct 23, 2017	Substantially Equivalent	TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD
K172596	Large Screws Range	Oct 02, 2017	Substantially Equivalent	Newclip Technics
K163148	BePOD® Foot Screws	Sep 14, 2017	Substantially Equivalent	Fournitures Hospitalieres Industrie
K163710	BePOD® EZ Weil Screws	Sep 08, 2017	Substantially Equivalent	Fournitures Hospitalieres Industrie
K162171	S4 Screw System	Sep 07, 2017	Substantially Equivalent	SUBCHONDRAL SOLUTIONS
K171558	ExsoMed ITN Cannulated Screw System	Sep 01, 2017	Substantially Equivalent	Exsomed Holdings Company, LLC
K171407	ExsoMed ArcPhix and ExsoMed ArrowPhix	Aug 18, 2017	Substantially Equivalent	ExsoMed Holding Company, LLC
K170782	Medline UNITE® Snap-Off Screws	Aug 18, 2017	Substantially Equivalent	Medline Industries, Inc.
K170624	TalarLift STS	Aug 11, 2017	Substantially Equivalent	Fusion Orthopedics, LLC
K170038	FuzeFix Screw System	Aug 07, 2017	Substantially Equivalent	Fusion Orthopedics, LLC
K162153	Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System	Jul 14, 2017	Substantially Equivalent	ASCENSION ORTHOPEDICS
K171018	Axis Charcot Fixation System, 4.5 to 8.5mm Screw System	Jul 13, 2017	Substantially Equivalent	Extremity Medical, LLC.
K171448	Hammertoe Correction System	Jul 07, 2017	Substantially Equivalent	Life Spine Inc.
K162874	Cannulated Screws Neoortho	Jun 27, 2017	Substantially Equivalent	Neoortho Produtos Ortopedicos S/A
K170571	Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw	Jun 20, 2017	Substantially Equivalent	Tyber Medical, LLC
K162685	2-Piece Hammertoe Correction System	Jun 09, 2017	Substantially Equivalent	Life Spine, Inc.
K170687	Flower Bone Screw Set	Jun 06, 2017	Substantially Equivalent	Flower Orthopedics Corporation
K170698	ALLY(TM) Bone Screws	May 31, 2017	Substantially Equivalent	Providence Medical Technology, Inc.
K170021	SMV Scientific Cannulated Screws	May 22, 2017	Substantially Equivalent	SMV Scientific
K170382	Arthrex Compression Screws	May 11, 2017	Substantially Equivalent	Arthrex Inc.
K170594	I.B.S. osteosynthesis screws	May 10, 2017	Substantially Equivalent	In2Bones SAS
K162825	CAPTIVATE Compression Screws	May 01, 2017	Substantially Equivalent	GLOBUS MEDICAL, INC.
K170889	HV Screw System	Apr 26, 2017	Substantially Equivalent	Wright Medical Technology, Inc.
K170012	Foot and Hand Motion	Apr 24, 2017	Substantially Equivalent	NEWCLIP TECHNICS
K162353	MICATM Screw System	Apr 13, 2017	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K170040	BePOD Cannulated Arthrodesis Screws	Apr 04, 2017	Substantially Equivalent	Fournitures Hospitalieres Industrie
K163303	OsteoMed ExtremiFix Mid and Large Screw System	Apr 04, 2017	Substantially Equivalent	OsteoMed LLC
K163489	OrthoSolutions 'System26' Bone Screws	Mar 08, 2017	Substantially Equivalent	Ortho SOlutions UK Limited
K170350	ToeMATE® Hammertoe Correction System	Mar 03, 2017	Substantially Equivalent	Arthrosurface, Inc.
K163038	EPIC Extremity Snap-Off Screw	Feb 28, 2017	Substantially Equivalent	EPIC EXTREMITY, LLC
K161894	SurgTech Trauma System	Feb 21, 2017	Substantially Equivalent	SURGTECH INC
K161616	DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw	Feb 16, 2017	Substantially Equivalent	Synthes USA Products, LLC
K161334	RASL Repair Kit	Feb 09, 2017	Substantially Equivalent	RADICLE ORTHOPAEDICS, INC.
K161904	GEO Bone Screw System	Jan 18, 2017	Substantially Equivalent	GRAMERCY EXTREMITY ORTHOPEIDICS, LLC
K161259	KLS Martin Cannulated Headless Screws	Dec 19, 2016	Substantially Equivalent	KLS MARTIN LP
K160946	4.0 and 6.5 Cancellous Bone Screw and Washer	Dec 05, 2016	Substantially Equivalent	SMV SCIENTIFIC
K161778	ToeTac 10° Hammertoe Fixation System	Nov 22, 2016	Substantially Equivalent	RESTORE SURGICAL LLC DBA INSTRATEK
K161597	Tyber Medical BioTy® Nanotopography Trauma Screw	Nov 16, 2016	Substantially Equivalent	TYBER MEDICAL LLC
K160791	AmorChem Titanium Porous Fixation Device	Nov 15, 2016	Substantially Equivalent	AmorChem Holdings, Inc.
K161449	HammerTech Fixation System	Oct 11, 2016	Substantially Equivalent	Fusion Orthopedics, LLC
K160174	I.B.S. 2.0 Osteosynthesis screw	Oct 06, 2016	Substantially Equivalent	In2Bones SAS
K153065	The Hammertoe Correction System	Aug 01, 2016	Substantially Equivalent	LIFE SPINE, INC
K161058	Cannulated Screw	Jul 29, 2016	Substantially Equivalent	MIAMI DEVICE SOLUTIONS, LLC
K161539	Arthrosurface Bone Screws	Jun 30, 2016	Substantially Equivalent	ARTHROSURFACE, INC.
K160169	The Life Spine Subtalar Implant System	Jun 23, 2016	Substantially Equivalent	Life Spine
K160617	Large Screws Range	Jun 03, 2016	Substantially Equivalent	NEWCLIP TECHNICS
K160427	dynaMX(TM) Nitinol Compression Screw	Jun 03, 2016	Substantially Equivalent	MX ORTHOPEDICS CORP.
K160548	MC-Subtalar(TM) II	Apr 29, 2016	Substantially Equivalent	MERETE MEDICAL GMBH
K160304	OsteoBullet Compression Screw	Apr 29, 2016	Substantially Equivalent	Phalanx Innovations
K153638	Bicortical Fixation Screw & Washer Nut System	Apr 19, 2016	Substantially Equivalent	FIRST RAY LLC
K160603	SMV Scientific Schanz Screws	Mar 28, 2016	Substantially Equivalent	SMV SCIENTIFIC
K160058	Biomet Variable Pitch Compression Screw System	Mar 09, 2016	Substantially Equivalent	Biomet Inc
K151708	RECON system - Compression Screws	Mar 02, 2016	Substantially Equivalent	NORMED MEDIZIN-TECHNIK GMBH
K153575	Tyber Medical Trauma Screw	Feb 26, 2016	Substantially Equivalent	TYBER MEDICAL LLC
K153759	SIGN Compression Screw System	Feb 25, 2016	Substantially Equivalent	SIGN FRACTURE CARE INTERNATIONAL
K152187	MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws	Feb 12, 2016	Substantially Equivalent	MERETE MEDICAL GMBH
K143596	MINIARS SCREWS	Feb 05, 2016	Substantially Equivalent	OVERMED SRL.
K151701	Tenodesis screw system	Jan 26, 2016	Substantially Equivalent	NORMED MEDIZIN-TECHNIK GMBH
K153333	Epic Extremity Cannulated Screw System	Jan 19, 2016	Substantially Equivalent	Epic Extremity, LLC
K153338	Tiger Cannulated Screw System	Jan 14, 2016	Substantially Equivalent	Trilliant Surgical, LTD
K153154	Asnis JFX System	Dec 28, 2015	Substantially Equivalent	Stryker Trauma AG
K153378	Monster BITE Screw System	Dec 21, 2015	Substantially Equivalent	PARAGON 28
K153182	SELF- COMPRESSIVE SCREW	Nov 25, 2015	Substantially Equivalent	NEOSTEO
K153180	Tyber Medical MST Trauma Screw	Nov 25, 2015	Substantially Equivalent	TYBER MEDICAL LLC
K152841	Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws	Nov 24, 2015	Substantially Equivalent	ZIMMER, INC.
K150211	EzFuze Implant System	Nov 10, 2015	Substantially Equivalent	VILEX IN TENNESSEE, INC.
K152527	Integra DigiFuse Cannulated Intramedullary Fusion System	Oct 29, 2015	Substantially Equivalent	Ascension Orthopedics
K152710	HammerFiX Device	Oct 15, 2015	Substantially Equivalent	EXTREMITY MEDICAL, LLC
K150693	PHIN-FX Cannulated Lag Screw System	Oct 13, 2015	Substantially Equivalent	ASCENT MEDICAL, LLC
K152072	CrossRoads Screw System	Sep 23, 2015	Substantially Equivalent	CrossRoads Extremity Systems, LLC
K151838	PRO-TOE Hammertoe Fixation System	Sep 04, 2015	Substantially Equivalent	Wright Medical Technology, Inc.
K151270	CrossTIE Intraosseous Fixation System	Sep 04, 2015	Substantially Equivalent	CrossRoads Extremity Systems LLC
K151241	Synchro-Medical TIGER TRACK Screw System	Aug 07, 2015	Substantially Equivalent	Synchro Medical
K150871	ForeFoot STP System	Aug 04, 2015	Substantially Equivalent	TORNIER, INC.
K151146	N-Force Fixation System	Jul 24, 2015	Substantially Equivalent	INNOVISION, INC.
K151418	Monster Screw System	Jul 15, 2015	Substantially Equivalent	PARAGON 28
K151021	OsteoMed Cannulated Screw System	Jul 15, 2015	Substantially Equivalent	OSTEOMED CORP.
K150981	SMV Scientific Bone Screws	Jun 23, 2015	Substantially Equivalent	SMV Scientific
K150376	Sonoma Cancellous Bone Screw and Washer	Jun 12, 2015	Substantially Equivalent	Sonoma Orthopedics Products, Inc
K150443	ToeTac Hammertoe Fixation System	Jun 04, 2015	Substantially Equivalent	RESTORE SURGICAL LLC dba Instratek
K151173	Biomet Microfixation RibFix Blu Thoracic Fixation System	May 26, 2015	Substantially Equivalent	Biomet Microfixation
K151078	Arthrex RetroFusion Screw	May 15, 2015	Substantially Equivalent	ARTHREX, INC.
K150126	Life Spine Cannulated Screws	May 11, 2015	Substantially Equivalent	LIFE SPINE INC.
K150772	Snap-Off Self-Compressive Screw	May 08, 2015	Substantially Equivalent	NEOSTEO
K150213	Subtalar Spacer System (STS)	May 08, 2015	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K150974	aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium	Apr 29, 2015	Substantially Equivalent	AAP IMPLANTATE AG
K150252	PHALINX Hammertoe System	Apr 29, 2015	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K150188	SMV Scientific 4.5 mm Bone Screws	Apr 29, 2015	Substantially Equivalent	SUMMIT MEDVENTURES
K143165	Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw	Mar 31, 2015	Substantially Equivalent	Zimmer, Inc.
K142776	Flow-Screw	Mar 23, 2015	Substantially Equivalent	Flow-FX, LLC
K150309	Extremity Medical Calcaneal Osteotomy Device	Mar 04, 2015	Substantially Equivalent	EXTREMITY MEDICAL, LLC
K141401	EASY OUT	Feb 20, 2015	Substantially Equivalent	FEET FOR LIFE PODIATRY CENTER
K143229	Nexis osteosynthesis compressive screws	Feb 06, 2015	Substantially Equivalent	NOVASTEP
K143146	Nexis osteosynthesis snap-off screws	Feb 06, 2015	Substantially Equivalent	NOVASTEP
K143402	Extremity Medical Calcaneal Osteotomy Device	Feb 04, 2015	Substantially Equivalent	EXTREMITY MEDICAL LLC
K143460	Cannulated Screw System	Jan 23, 2015	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K143614	Arthrex Low Profile Screws	Jan 16, 2015	Substantially Equivalent	ARTHREX, INC.
K143039	CrossRoads Screw System	Jan 16, 2015	Substantially Equivalent	ORTHODISCOVERY GROUP LLC (D.B.A. CROSSROADS EXTREM
K143624	Headless Compression Screw System	Jan 13, 2015	Substantially Equivalent	SKELETAL DYNAMICS, LLC
K142057	INFIX CANNULATED SCREW SYSTEM	Jan 13, 2015	Substantially Equivalent	INFIX MEDICAL LLC
K141857	CrossTie Intraosseous Fixation System	Jan 08, 2015	Substantially Equivalent	ORTHODISCOVERY GROUP LLC (D.B.A. CROSSROADS EXTREM
K143188	3.Omm Biomet Cannulated Screw System	Dec 30, 2014	Substantially Equivalent	BIOMET MANUFACTURING CORP.
K142528	AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mm	Dec 22, 2014	Substantially Equivalent	Agent Medical, LLC
K142707	AIS Odontoid Fracture Fixation System	Dec 19, 2014	Substantially Equivalent	AESCULAP IMPLANT SYSTEM, INC.
K142490	ProxiFuse Hammer Toe Device	Dec 15, 2014	Substantially Equivalent	Cartiva, Inc.
K142585	PhaLinx Hammertoe System	Nov 20, 2014	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K130019	J-SCREW COMPRESSION SCREW	Nov 18, 2014	Substantially Equivalent	COMPETITIVE ENGINEERING INC.
K142658	Biomet Headless Compression and Twist-off Screws	Nov 13, 2014	Substantially Equivalent	BIOMET MANUFACTURING CORP.
K142534	HyProCure II	Oct 03, 2014	Substantially Equivalent	Graham Medical Technologies, L.L.C. dba GraMedica
K142442	MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM	Oct 03, 2014	Substantially Equivalent	ZIMMER, INC.
K141290	HELICAL RIDGE PEEK INTERFERENCE SCREW	Sep 29, 2014	Substantially Equivalent	MEDSHAPE, INC
K141949	CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM	Sep 12, 2014	Substantially Equivalent	AAP IMPLANTATE AG
K141937	TRIDENT FUSION IMPLANT	Sep 10, 2014	Substantially Equivalent	VILEX IN TENNESSEE, INC.
K132912	DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT	Jul 30, 2014	Substantially Equivalent	IN2BONES SAS
K140962	NORMED VARIO SUBTALAR SCREW	Jul 03, 2014	Substantially Equivalent	NORMED NEDIZIN TECHNIK GMBH
K140891	BIOMET CANNULATED SCREW SYSTEM	Jun 03, 2014	Substantially Equivalent	BIOMET, INC.
K140952	CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW	May 15, 2014	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K140741	SALVATION BEAMS AND BOLTS SYSTEM	May 15, 2014	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K133662	SMITH & NEPHEW CANNULATED CAPTURED SCREW	May 15, 2014	Substantially Equivalent	SMITH & NEPHEW, INC.
K140408	SALVATION OSTEOPENIC SCREW	May 14, 2014	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K140970	ONE-PIECE PEEK FUSION IMPLANT	May 13, 2014	Substantially Equivalent	MTP SOLUTIONS LLC
K131920	STABILIZATION SCREW	May 01, 2014	Substantially Equivalent	IN2BONES SAS
K132911	I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW	Apr 04, 2014	Substantially Equivalent	IN2BONES SAS
K133636	EXTREMITY MEDICAL HAMMERTOE DEVICE	Mar 28, 2014	Substantially Equivalent	EXTREMITY MEDICAL, LLC.
K133515	PEEK FUSION IMPLANT	Mar 28, 2014	Substantially Equivalent	MTP SOLUTIONS LLC
K133842	TYBER MEDICAL TRAUMA SCREW	Mar 20, 2014	Substantially Equivalent	TYBER MEDICAL LLC
K140148	PRO-TOE HAMMERTOE FIXATION SYSTEM	Mar 07, 2014	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K133713	CHARLOTTE (TM) SNAP-OFF SCREW	Mar 07, 2014	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K132244	N-FORCE FIXATION SYSTEM	Mar 06, 2014	Substantially Equivalent	INNOVISION, INC.
K140283	OSTEOMED EXTREMIFUSE SYSTEM	Feb 28, 2014	Substantially Equivalent	OSTEOMED
K133451	FIXOS SCREW SYSTEM	Feb 28, 2014	Substantially Equivalent	Stryker Trauma AG
K130613	CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM	Jan 22, 2014	Substantially Equivalent	LAURA CATTABRIGA
K133460	APTUS CANNULATED COMPRESSION SCREWS	Dec 18, 2013	Substantially Equivalent	MEDARTIS AG
K133440	AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION	Dec 18, 2013	Substantially Equivalent	Stryker Trauma AG
K132910	DEPUY SYNTHES SPINE DENS ACCESS SYSTEM	Dec 16, 2013	Substantially Equivalent	SYNTHES USA PRODUCTS, LLC
K133035	NORMED PELLEGRIN CALCANEUS STOP SCREW	Dec 13, 2013	Substantially Equivalent	NORMED MEDIZIN-TECHNIK GMBH
K131591	FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)	Nov 27, 2013	Substantially Equivalent	PEGA MEDICAL INC.
K132217	ARTHREX COMPRESSION FT SCREWS	Nov 25, 2013	Substantially Equivalent	ARTHREX, INC.
K132893	EDGE ORTHOPAEDICS BITE COMPRESSION SCREW	Nov 20, 2013	Substantially Equivalent	ICON ORTHOPAEDIC CONCEPTS DBA EDGE ORTHOPAEDICS
K132248	FLOWER BONE SCREW SET	Oct 30, 2013	Substantially Equivalent	FLOWER ORTHOPEDICS CORPORATION
K130810	ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM	Sep 19, 2013	Substantially Equivalent	ZIMMER, INC.
K131471	SELF-COMPRESSIVE SCREW	Aug 28, 2013	Substantially Equivalent	NEOSTEO
K130627	SWING-OFF SCREW	Aug 21, 2013	Substantially Equivalent	ADVANCED INTERVENTIONAL TECHNOLOGY, LLC
K131264	KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS	Jul 26, 2013	Substantially Equivalent	GEBR. BRASSELER GMBH & CO. KG
K131620	JONES-FX FRACTURE SYSTEM	Jul 25, 2013	Substantially Equivalent	INSTRATEK, INC.
K130859	HAMMERTOE CORRECTION SYSTEM	Jul 25, 2013	Substantially Equivalent	ARTHROSURFACE, INC.
K131324	MAXTORQUE SCREW SYSTEM	May 31, 2013	Substantially Equivalent	ORTHOHELIX SURGICAL DESIGNS, INC.
K130954	ARS SCREW; SLANT SCREW	May 31, 2013	Substantially Equivalent	ADVANCED INTERVENTIONAL TECHNOLOGY, LLC
K130412	OSTEOMED EXTREMIFUSE SYSTEM	May 31, 2013	Substantially Equivalent	OSTEOMED
K130319	MEDLINE CANNULATED SCREW	May 31, 2013	Substantially Equivalent	MEDLINE INDUSTRIES, INC.
K130590	AAP CANNULATED SCREW 2.0	Apr 22, 2013	Substantially Equivalent	AAP IMPLANTATE AG
K130120	EXTREMITY MEDICAL IP FUSION SYSTEM	Apr 11, 2013	Substantially Equivalent	EXTREMITY MEDICAL, LLC
K130400	MERETEC CS, CORTICAL SCREWS	Apr 05, 2013	Substantially Equivalent	MERETE MEDICAL GMBH
K124027	MONSTER SCREW SYSTEM	Apr 05, 2013	Substantially Equivalent	APOGEE ORTHOSOLUTIONS
K123890	ACUMED CANNULATED SCREW SYSTEM	Mar 18, 2013	Substantially Equivalent	ACUMED LLC
K123672	INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)	Feb 27, 2013	Substantially Equivalent	INION OY
K123362	MILAGRO ADVANCE INTERFERENCE SCREW	Feb 01, 2013	Substantially Equivalent	DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
K122489	EMERGE MEDICAL SOLID BONE SCREWS	Dec 10, 2012	Substantially Equivalent	EMERGE MEDICAL
K122596	ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS	Nov 20, 2012	Substantially Equivalent	SMITH & NEPHEW, INC.
K122959	HAMMER TOE IMPLANT	Nov 07, 2012	Substantially Equivalent	TRILLIANT SURGICAL LTD
K122738	GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET	Nov 07, 2012	Substantially Equivalent	SOLANA SURGICAL LLC
K121277	Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE	Nov 07, 2012	Substantially Equivalent	Z-MEDICAL GMBH & CO. KG
K122031	NEXTRA TI HAMMERTOE CORRECTION SYSTEM	Oct 09, 2012	Substantially Equivalent	NEXTREMITY SOLUTIONS, LLC
K121682	ACTIVE SCREW BONE SCREW	Oct 04, 2012	Substantially Equivalent	INTELLIGENT IMPLANT SYSTEMS, LLC
K121713	PMT BONE SCREWS	Sep 27, 2012	Substantially Equivalent	PROVIDENCE MEDICAL TECHNOLOGY, INC.
K121148	SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D	Aug 20, 2012	Substantially Equivalent	MEDICAL DESIGN LLC.
K121417	XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM	Jul 18, 2012	Substantially Equivalent	EXTREMITY MEDICAL LLC
K121349	IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER	Jul 18, 2012	Substantially Equivalent	EXTREMITY MEDICAL LLC
K113388	CITIEFFE-TITANIUM CANNULATED SCREW	Jun 05, 2012	Substantially Equivalent	CITIEFFE
K113006	I-FUSE HAMMER TOE SYSTEMS	May 25, 2012	Substantially Equivalent	ORTHOPRO LLC
K120493	MINI CANNULATED HEADED AND HEADLESS SCREW SET	May 17, 2012	Substantially Equivalent	INSTRATEK, INC.
K120449	HEALIX ADVANCE PEEK ANCHOR	May 11, 2012	Substantially Equivalent	Depuy Mitek
K120645	PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION	Apr 24, 2012	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K120390	SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET	Apr 10, 2012	Substantially Equivalent	SOLANA SURGICAL LLC
K111971	SYNDE-LOCK SYNDESMOSIS REPAIR KIT	Jan 23, 2012	Substantially Equivalent	TARSUS MEDICAL INC.
K112727	MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL FACETS HEADLESS COMPRESSION SCREWS, MEDICAL	Jan 13, 2012	Substantially Equivalent	MEDICAL FACETS
K112240	DYNA LOCKING CANNULATED SCREW	Jan 04, 2012	Substantially Equivalent	U&I CORP.
K113591	COLS PEEK	Dec 22, 2011	Substantially Equivalent	FOURNITURES HOSPITALIERES INDUSTRIE
K113399	IFS SUBTALAR IMPLANT	Dec 20, 2011	Substantially Equivalent	INTERNAL FIXATION SYSTEMS, INC.
K112885	ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY	Dec 19, 2011	Substantially Equivalent	ZIMMER, INC.
K110895	ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS	Dec 19, 2011	Substantially Equivalent	ORTHO SOLUTIONS LIMITED
K112672	HEADLESS COMPRESSION SCREW	Dec 13, 2011	Substantially Equivalent	SKELETAL DYNAMICS, LLC
K112658	OSTEOSPRING FOOTJACK SUBTALAR IMPLANT SYSTEM	Dec 12, 2011	Substantially Equivalent	OSTEOSPRING MEDICAL, INC
K113084	RENOVIS CANNULATED SCREW SYSTEM	Dec 09, 2011	Substantially Equivalent	RENOVIS SURGICAL TECHNOLOGIES, LLC
K112028	SI-LOK SACROILIAC JOINT FIXATION SYSTEM	Dec 09, 2011	Substantially Equivalent	GLOBUS MEDICAL, INC.
K111834	DISCO SUBTALAR IMPLANT	Dec 06, 2011	Substantially Equivalent	TRILLIANT SURGICAL LTD
K112583	SYNTHES CORTICAL SCREWS	Dec 05, 2011	Substantially Equivalent	SYNTHES (USA) PRODUCTS LLC
K111908	BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM	Nov 29, 2011	Substantially Equivalent	BIOMET MICROFIXATION, INC.
K112737	TIGER HEADLESS CANNULATED SCREWS	Oct 20, 2011	Substantially Equivalent	TRILLIANT SURGICAL LTD
K111994	SMITH & NEPHEW CANNULATED SCREWS AND WASHERS	Oct 11, 2011	Substantially Equivalent	SMITH & NEPHEW, INC.
K112772	ORTHOLOC(TM) BONE SCREWS	Oct 07, 2011	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K111447	ZIMMER PERIARTICULAR SCREWS	Oct 05, 2011	Substantially Equivalent	ZIMMER INC.
K112237	MICROSUTURE ANCHORS	Sep 02, 2011	Substantially Equivalent	ARTHREX, INC.
K111608	SLIC SCREW REPAIR SYSTEM	Aug 29, 2011	Substantially Equivalent	ACUMED LLC
K111799	NUGAIT(TM) SUBTALAR IMPLANT SYSTEM	Aug 19, 2011	Substantially Equivalent	ASCENSION ORTHOPEDIC
K111265	METASURG SUBTALAR IMPLANT	Aug 09, 2011	Substantially Equivalent	METASURG
K111000	PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR	Jul 28, 2011	Substantially Equivalent	PARCUS MEDICAL, LLC
K102528	N-FORCE FIXATION SYSTEM	Jul 28, 2011	Substantially Equivalent	INNOVISION, INC.
K110592	3.7MM/5.0MM DYNAMIC LOCKING SCREW	Jul 25, 2011	Substantially Equivalent	SYNTHES USA
K111536	METASURG DIGIFUSE IMPLANT	Jul 21, 2011	Substantially Equivalent	METASURG
K111316	AAP CANNULATED SCREWS	Jul 20, 2011	Substantially Equivalent	AAP IMPLANTATE AG
K110538	PRO FIXATION SYSTEM	Jul 12, 2011	Substantially Equivalent	SYNOVIS ORTHOPEDIC & WOUNDCARE
K110658	APTUS CANNULATED COMPRESSION SCREWS	Jun 02, 2011	Substantially Equivalent	MEDARTIS AG
K111230	SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW	May 24, 2011	Substantially Equivalent	SYNTHES (USA) PRODUCTS LLC
K111001	STERILE STORM (R) OPERATING KIT	May 17, 2011	Substantially Equivalent	INTELLIGENT ORTHOPAEDICS LTD
K102324	ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM	May 04, 2011	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K110763	LATARJET CORTICAL SCREW SET	Apr 11, 2011	Substantially Equivalent	T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
K103705	LOW PROFILE SCREWS	Mar 18, 2011	Substantially Equivalent	ARTHREX, INC.
K110445	FLEXFUSION (TM) FIXATION IMPLANT	Mar 17, 2011	Substantially Equivalent	NEXTREMITY SOLUTIONS, LLC
K103712	GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD	Mar 11, 2011	Substantially Equivalent	DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
K103183	TRILLIANT SURGICAL SUBTALAR IMPLANT	Feb 08, 2011	Substantially Equivalent	TRILLIANT SURGICAL LTD
K102298	TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND	Jan 07, 2011	Substantially Equivalent	DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
K102410	MATRYX INTERFERENCE SCREW (5.0-6.5MM)	Dec 21, 2010	Substantially Equivalent	CONMED LINVATEC
K102343	EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM	Nov 23, 2010	Substantially Equivalent	EMERGE MEDICAL
K100721	LOCKING BONE SCREW MODEL HCQ04, HCZ04	Nov 23, 2010	Substantially Equivalent	CHANGZHOU ORTHMAR MEDICAL INSTRUMENT CO., LTD.
K093055	CSTS SCREW	Nov 22, 2010	Substantially Equivalent	ORTHOPRO LLC
K102326	PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR	Nov 15, 2010	Substantially Equivalent	PARCUS MEDICAL, LLC
K102162	PARCUS PEEK CF PUSH-IN SUTURE ANCHOR	Nov 10, 2010	Substantially Equivalent	PARCUS MEDICAL, LLC
K101808	SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER	Nov 08, 2010	Substantially Equivalent	MEDSHAPE SOLUTIONS
K102903	PIONEER CANNULATED SCREW SYSTEM	Oct 20, 2010	Substantially Equivalent	PIONEER SURGICAL TECHNOLOGY, INC.
K101700	IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM	Oct 12, 2010	Substantially Equivalent	EXTREMITY MEDICAL LLC
K101696	MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM	Sep 10, 2010	Substantially Equivalent	ZIMMER, INC.
K101165	PRO-TOE VO HAMMERTOW IMPLANT SYSTEM	Jul 23, 2010	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K101254	NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM	Jul 15, 2010	Substantially Equivalent	TECNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V
K100359	DARCO HEADED CANNULATED SCREW	Jun 24, 2010	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K093078	UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS	Jun 23, 2010	Substantially Equivalent	BONUTTI RESEARCH, INC.
K101030	MODIFICATION TO HBS HEADLESS BONE SCREW	Jun 03, 2010	Substantially Equivalent	BIOPRO, INC.
K093820	SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115	May 19, 2010	Substantially Equivalent	MEMOMETAL TECHNOLOGIES
K100325	PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES	May 04, 2010	Substantially Equivalent	SMITH & NEPHEW, INC.
K093770	EXTREMITY MEDICAL SCREW SYSTEM	Apr 28, 2010	Substantially Equivalent	EXTREMITY MEDICAL LLC
K100457	OPUS SPEEDSCREW SYSTEM	Mar 19, 2010	Substantially Equivalent	ARTHROCARE CORP.
K100532	VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819	Mar 17, 2010	Substantially Equivalent	DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
K093676	OMNITECH LARGE, TRIMED COMPRESSION SCREW	Mar 17, 2010	Substantially Equivalent	TRIMED, INC.
K092754	SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061	Jan 19, 2010	Substantially Equivalent	SMALL BONE INNOVATIONS INC.
K092909	SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE)	Jan 11, 2010	Substantially Equivalent	SYNTHES (USA)
K091118	FOOT AND HAND MOTION SYSTEM	Dec 16, 2009	Substantially Equivalent	NEWCLIP TECHNICS
K091686	LEFORTE NEUROSYSTEM BONE SCREW	Nov 13, 2009	Substantially Equivalent	JEIL MEDICAL CORPORATION
K092440	ASCENSION CANNULATED SCREW SYSTEM	Nov 05, 2009	Substantially Equivalent	ASCENSION ORTHOPEDICS, INC.
K092133	ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N	Nov 05, 2009	Substantially Equivalent	ARTHROCARE CORP.
K092082	SYNERGY CANNULATED SCREW SYSTEM	Oct 02, 2009	Substantially Equivalent	SYNERGY SURGICAL TECHNOLOGIES, LLC
K091093	PARCUS PPEK CF INTERFERENCE SCREW	Sep 30, 2009	Substantially Equivalent	PARCUS MEDICAL, LLC
K092189	POGO SCREW	Sep 18, 2009	Substantially Equivalent	FXDEVICES
K091202	WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS,	Sep 16, 2009	Substantially Equivalent	MEDSHAPE SOLUTIONS
K090175	UNITY BETA PLLA SYSTEM	Sep 10, 2009	Substantially Equivalent	BONUTTI RESEARCH, INC.
K091798	MERETE COMPRESSION SCREWS	Sep 02, 2009	Substantially Equivalent	MERETE MEDICAL GMBH
K090949	SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS	Jul 31, 2009	Substantially Equivalent	SYNTHES (USA)
K091577	EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM	Jul 24, 2009	Substantially Equivalent	EXTREMITY MEDICAL LLC
K083912	TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS	Jul 15, 2009	Substantially Equivalent	TREU-INSTRUMENTE GMBH
K091694	MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM)	Jul 07, 2009	Substantially Equivalent	T.A.G. MEDICAL PRODUCTS
K090656	INTERTAN CHS LIMITED COLLAPSE SET SCREW	Jun 03, 2009	Substantially Equivalent	SMITH & NEPHEW, INC.
K091069	MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT	Jun 01, 2009	Substantially Equivalent	MEDACTA INTERNATIONAL, SA
K081122	FUSION MEDICAL CANNULATED SCREW SYSTEM	May 26, 2009	Substantially Equivalent	JOHN RICCIO
K081755	FUSION MEDICAL STI	May 20, 2009	Substantially Equivalent	JOHN RICCIO
K090994	LIGAFIX INTERFACE SCREW	May 06, 2009	Substantially Equivalent	SCIENCE FOR BIOMATERIALS
K082934	EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM	Apr 23, 2009	Substantially Equivalent	EXTREMITY MEDICAL LLC
K083096	LATARJET CORTICAL SCREW SET	Apr 17, 2009	Substantially Equivalent	T.A.G. MEDICAL PRODUCTS
K083792	WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055	Mar 25, 2009	Substantially Equivalent	MEDSHAPE SOLUTIONS
K081813	UNIVERSAL COMPRESSION FRACTURE REPAIR SYSTEM	Mar 12, 2009	Substantially Equivalent	U.S. IMPLANT SOLUTIONS, LLC
K083619	PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020	Mar 06, 2009	Substantially Equivalent	PARCUS MEDICAL, LLC
K083612	APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM	Mar 04, 2009	Substantially Equivalent	CAYENNE MEDICAL, INC.
K083607	APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM	Mar 04, 2009	Substantially Equivalent	CAYENNE MEDICAL, INC.
K082874	BIODRIVE CANNULATED SCREW SYSTEM	Feb 05, 2009	Substantially Equivalent	BIOMET TRAUMA
K082574	MAXTORQUE MINI CANNULATED SCREW SYSTEM	Dec 08, 2008	Substantially Equivalent	ORTHOHELIX SURGICAL DESIGNS, INC.
K082949	ORTHOPEDIATRICS BONE SCREWS	Nov 25, 2008	Substantially Equivalent	ORTHOPEDIATRICS, CORP.
K080649	POGO SCREW	Nov 25, 2008	Substantially Equivalent	FXDEVICES
K082282	HEALIX TI ANCHOR	Nov 07, 2008	Substantially Equivalent	DEPUY MITEK, A JOHNSON & JOHNSON CO.
K081011	AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45	Nov 07, 2008	Substantially Equivalent	AREX USA
K082320	DARCO SMALL SCREW	Nov 05, 2008	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K082906	UNITY BETA ANCHOR SYSTEM	Oct 30, 2008	Substantially Equivalent	BONUTTI RESEARCH, INC.
K081893	OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500	Oct 01, 2008	Substantially Equivalent	ARTHROCARE CORP.
K082516	PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS	Sep 17, 2008	Substantially Equivalent	SMITH & NEPHEW, INC.
K081934	EXTREMITY MEDICAL COMPRESSION SCREW	Aug 29, 2008	Substantially Equivalent	EXTREMITY MEDICAL LLC
K080259	JMEA CANNULATED BONE SCREW SYSTEM	Aug 20, 2008	Substantially Equivalent	JMEA CORPORATION
K081390	BIOACTIF OSTEOTRANS INTERFENCE SCREW	Aug 12, 2008	Substantially Equivalent	TAKIRON CO., LTD
K081149	BIOPRO GO-EZ SCREW	Aug 05, 2008	Substantially Equivalent	BIOPRO, INC.
K081510	TIGER CANNULATED SCREW SYSTEM	Aug 04, 2008	Substantially Equivalent	TRILLIANT SURGICAL LTD
K073159	TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5	Jul 23, 2008	Substantially Equivalent	TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD.
K081513	MERETE 3.0 AND 3.5 MM LOCKING SCREWS	Jul 18, 2008	Substantially Equivalent	MERETE MEDICAL GMBH
K081700	SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION	Jul 17, 2008	Substantially Equivalent	SYNTHES (USA)
K072291	CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR	Jul 14, 2008	Substantially Equivalent	CONMED LINVATEC
K080778	ENSPLINT TM BONE SCREW	Jul 10, 2008	Substantially Equivalent	SONOMA ORTHOPEDIC PRODUCTS, INC.
K080974	TLS FIXATION SYSTEM	Jul 01, 2008	Substantially Equivalent	FOURNITURES HOSPITALIERES INDUSTRIE
K081428	MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR	Jun 20, 2008	Substantially Equivalent	BIOCOMPOSITES LTD.
K081392	BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN	Jun 18, 2008	Substantially Equivalent	BIORETEC LTD
K080088	BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS	Jun 11, 2008	Substantially Equivalent	BIOMET MANUFACTURING, INC.
K073312	OSTEOTRANS-OT SCREW	May 13, 2008	Substantially Equivalent	TAKIRON CO., LTD
K081071	SYNTHES 6.5MM MIDFOOT FUSION BOLT	May 01, 2008	Substantially Equivalent	SYNTHES (USA)
K080943	SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS	Apr 23, 2008	Substantially Equivalent	SYNTHES (USA)
K080358	PLLA, HA SCREW	Apr 23, 2008	Substantially Equivalent	SMITH & NEPHEW INC., ENDOSCOPY DIV.
K080850	DARCO HEADLESS COMPRESSION SCREW	Apr 10, 2008	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K080101	AAP CANNULATED SCREW AND DARCO HEADED SCREW	Mar 25, 2008	Substantially Equivalent	AAP IMPLANTATE AG
K080280	SUB-TALAR LOK, MODEL 7-11 MM	Mar 14, 2008	Substantially Equivalent	INSTRATEK, INC.
K080352	MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE	Mar 12, 2008	Substantially Equivalent	DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
K073509	TWINFIX PK FP SUTURE ANCHOR	Mar 04, 2008	Substantially Equivalent	SMITH & NEPHEW, INC.
K073426	APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM	Feb 19, 2008	Substantially Equivalent	CAYENNE MEDICAL, INC.
K072785	TWINFIX FT PK	Dec 10, 2007	Substantially Equivalent	SMITH & NEPHEW INC., ENDOSCOPY DIVISION
K071941	MEMOMETAL BONE ANCHORS	Dec 04, 2007	Substantially Equivalent	MEMOMETAL TECHNOLOGIES
K073054	MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER	Nov 27, 2007	Substantially Equivalent	CAYENNE MEDICAL, INC.
K072848	ACTIVASCREW	Nov 02, 2007	Substantially Equivalent	BIORETEC LTD
K071816	HARPOON SUTURE ANCHOR	Sep 20, 2007	Substantially Equivalent	BIOMET SPORTS MEDICINE, INC.
K071157	STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS	Sep 17, 2007	Substantially Equivalent	Stryker Endoscopy
K071437	MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C	Sep 12, 2007	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K071541	SBI TWISTOFIX	Sep 10, 2007	Substantially Equivalent	SMALL BONE INNOVATIONS INC.
K072127	DOMINATOR	Aug 31, 2007	Substantially Equivalent	BIOCOMPOSITES LTD.
K063635	SBI FOREFOOT SET	Aug 29, 2007	Substantially Equivalent	SMALL BONE INNOVATIONS, INC.
K071656	SBI ARTFIX	Aug 27, 2007	Substantially Equivalent	SMALL BONE INNOVATIONS INC.
K071952	GRAFTLOCK SCREW, ST SCREW	Aug 14, 2007	Substantially Equivalent	BIOCOMPOSITES LTD.
K071035	IFS BONE FIXATION DEVICES	Aug 13, 2007	Substantially Equivalent	INTERNAL FIXATION SYSTEMS, INC.
K071481	HEALIX ANCHOR	Aug 09, 2007	Substantially Equivalent	DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
K070389	PEEK KNOTLESS ANCHORS	Aug 09, 2007	Substantially Equivalent	BIOMET SPORTS MEDICINE, INC.
K071464	INION HEXALON BIODEGRADABLE ACL/PCL SCREW	Aug 03, 2007	Substantially Equivalent	INION OY
K071498	SUBTALAR IMPLANT	Jul 31, 2007	Substantially Equivalent	BIOMET SPORTS MEDICINE, INC.
K071639	QWIX POSITIONING SCREW	Jul 09, 2007	Substantially Equivalent	NEWDEAL SAS
K071177	ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW	Jun 29, 2007	Substantially Equivalent	ARTHREX, INC.
K070617	CANNULATED SCREW	Jun 14, 2007	Substantially Equivalent	FOURNITURES HOSPITALIERES INDUSTRIE
K071115	MODIFICATION TO BILOK ST SCREW	May 17, 2007	Substantially Equivalent	BIOCOMPOSITES LTD.
K071091	MODIFICATION TO BILOK SCREW	May 17, 2007	Substantially Equivalent	BIOCOMPOSITES LTD.
K071092	ASNIS MICRO CANNULATED SCREW	May 11, 2007	Substantially Equivalent	HOWMEDICA OSTEONICS CORP.
K070347	ALLOFIX PUSH-IN ANCHOR	May 11, 2007	Substantially Equivalent	MUSCULOSKELETAL TRANSPLANT FOUNDATION
K063584	STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937	May 09, 2007	Substantially Equivalent	REGENERATION TECHNOLOGIES, INC.
K070441	METASURG SUBTALAR IMPLANT	May 08, 2007	Substantially Equivalent	METASURG
K070393	LAGWIRE SYSTEM	May 04, 2007	Substantially Equivalent	FXDEVICES
K070906	MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS	May 01, 2007	Substantially Equivalent	ZIMMER, INC.
K070525	CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER	Mar 29, 2007	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K070507	MODIFICATION TO: LIGAFIX INTERFERENCE SCREW	Mar 29, 2007	Substantially Equivalent	SCIENCE FOR BIOMATERIALS
K070039	MEMOMETAL FIXOS SCREWS	Mar 21, 2007	Substantially Equivalent	MEMOMETAL TECHNOLOGIES
K062820	UNITY ALPHA SYSTEM	Mar 15, 2007	Substantially Equivalent	BONUTTI RESEARCH, INC.
K063588	MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5	Mar 02, 2007	Substantially Equivalent	CONMED LINVATEC BIOMATERIALS
K063298	OSTEOMED HEADLESS CANNULATED SCREW SYSTEM	Mar 02, 2007	Substantially Equivalent	OSTEOMED L.P.
K063589	GSO BONE FIXATION FASTENERS	Jan 31, 2007	Substantially Equivalent	GOLD STANDARD ORTHOPAEDICS LLC
K063244	ARC SURGICAL BONE REDUCTION SCREW	Dec 27, 2006	Substantially Equivalent	ARC SURGICAL LLC.
K063478	VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), ETHIBOND SUTURE (210809), AND PANACRYL SUTURE (210810)	Dec 15, 2006	Substantially Equivalent	DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
K063070	APERFIX TIBIAL IMPLANT WITH INSERTER	Dec 14, 2006	Substantially Equivalent	CAYENNE MEDICAL, INC.
K063479	ARTHREX PUSHLOCK	Dec 13, 2006	Substantially Equivalent	ARTHREX, INC.
K062980	ACTIVASCREW	Nov 22, 2006	Substantially Equivalent	BIORETEC LTD
K062487	APERFIX FEMORAL IMPLANT WITH INSERTER	Nov 17, 2006	Substantially Equivalent	CAYENNE MEDICAL, INC.
K062863	OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEM	Oct 31, 2006	Substantially Equivalent	OSTEOMED L.P.
K062103	DARCO FORCE TITANIUM COMPRESSION SCREW	Oct 25, 2006	Substantially Equivalent	DARCO INTERNATIONAL, INC.
K062352	FRS SCREW	Oct 19, 2006	Substantially Equivalent	DEPUY ORTHOPAEDICS, INC.
K061863	ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY	Oct 19, 2006	Substantially Equivalent	ARTHREX, INC.
K062617	MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM	Oct 04, 2006	Substantially Equivalent	INION LTD.
K062679	ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES	Sep 27, 2006	Substantially Equivalent	ARTHREX, INC.
K061949	DOUBLEPLAY SUTURE ANCHOR	Sep 25, 2006	Substantially Equivalent	BIOCOMPOSITES LTD.
K061763	ARC SURGICAL BIOTRAK SCREW	Sep 19, 2006	Substantially Equivalent	ARC SURGICAL LLC.
K062348	TIMESH SELF DRILLING SCREW	Sep 08, 2006	Substantially Equivalent	MEDTRONIC NEUROSURGERY
K061621	SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS	Jul 27, 2006	Substantially Equivalent	SYNTHES (USA)
K061620	IFS CANNULATED BONE SCREW	Jul 26, 2006	Substantially Equivalent	INTERNAL FIXATION SYSTEMS, INC.
K061665	ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT	Jul 25, 2006	Substantially Equivalent	ARTHREX, INC.
K061765	KALIX II IMPLANT	Jul 18, 2006	Substantially Equivalent	NEWDEAL S.A.
K061262	LIGAFIX INTERFERENCE SCREW	Jul 05, 2006	Substantially Equivalent	SCIENCES FOR BIO MATERIALS
K061206	ACUTE BONE SCREW	Jun 19, 2006	Substantially Equivalent	ACUTE INNOVATIONS LLC
K060830	MILAGRO INTERFERENCE SCREW	Jun 15, 2006	Substantially Equivalent	DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
K060249	ULTRATINE FOREHEAD	Jun 12, 2006	Substantially Equivalent	COAPT SYSTEMS, INC.
K060248	ULTRATINE TRANSBLEPH	Jun 12, 2006	Substantially Equivalent	COAPT SYSTEMS, INC.
K060914	TRIDENT ANCHOR	Jun 09, 2006	Substantially Equivalent	JOHNSON & JOHNSON COMPANY
K060693	MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR	Jun 06, 2006	Substantially Equivalent	ARTHROTEK, INC.
K060664	FASTIN RC ANCHOR	Jun 06, 2006	Substantially Equivalent	Depuy Mitek
K060478	ARTHREX BIO-COMPRESSION SCREW	May 19, 2006	Substantially Equivalent	ARTHREX, INC.
K060271	SPIRALOK ANCHOR	May 04, 2006	Substantially Equivalent	DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
K060710	UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS	Apr 26, 2006	Substantially Equivalent	ZIMMER, INC.
K060736	SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS	Apr 18, 2006	Substantially Equivalent	SMITH & NEPHEW, INC.
K060714	HI-FI ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR	Apr 06, 2006	Substantially Equivalent	CONMED LINVATEC
K053543	ARTHREX ARTHOERESIS IMPLANT	Apr 03, 2006	Substantially Equivalent	ARTHREX, INC.
K060393	INION HEXALON BIODEGRADABLE ACL/PCL SCREW	Mar 13, 2006	Substantially Equivalent	INION LTD.
K060428	CSS CANNULATED SCREW SYSTEM	Mar 07, 2006	Substantially Equivalent	ORTHOHELIX SURGICAL DESIGNS, INC.
K060253	STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.	Feb 23, 2006	Substantially Equivalent	REGENERATION TECHNOLOGIES, INC.
K053561	BIO-MINI REVO SUTURE ANCHOR	Feb 23, 2006	Substantially Equivalent	CONMED LINVATEC
K053344	BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE ANCHOR	Feb 23, 2006	Substantially Equivalent	SMITH & NEPHEW, INC.
K060071	NEXA COMPRESSION SCREW	Jan 26, 2006	Substantially Equivalent	NEXA ORTHOPEDICS, INC.
K060026	KOBY SURGICAL INTERNAL FIXATION SYSTEM	Jan 26, 2006	Substantially Equivalent	KOBY SURGICAL
K053338	ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS	Jan 26, 2006	Substantially Equivalent	ARTHREX, INC.
K053136	5TH METATARSAL FRACTURE SCREW	Jan 05, 2006	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K053394	NEXA BONE SCREW SYSTEM	Dec 14, 2005	Substantially Equivalent	NEXA ORTHOPEDICS, INC.
K053093	KALIX II IMPLANT, MODEL 141 0XX WITH XX	Dec 07, 2005	Substantially Equivalent	NEWDEAL S.A.
K052405	STERLING INTERFERENC SCREW HT	Nov 16, 2005	Substantially Equivalent	REGENERATION TECHNOLOGIES, INC.
K052607	ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS	Nov 07, 2005	Substantially Equivalent	ARTHREX, INC.
K052576	SBI AUTOFIX	Nov 07, 2005	Substantially Equivalent	SMALL BONE INNOVATIONS, LLC
K050407	LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60	Nov 04, 2005	Substantially Equivalent	SCIENCES FOR BIO MATERIALS
K052630	ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)	Oct 17, 2005	Substantially Equivalent	DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
K051726	ARTHREX TENODESIS FAMILY	Sep 27, 2005	Substantially Equivalent	ARTHREX, INC.
K050388	REFIX INTERNAL FRACTURE FIXATION SCREWS	Sep 07, 2005	Substantially Equivalent	XTREMI-T, LLC
K051611	MBARESORB IMPLANT	Sep 06, 2005	Substantially Equivalent	KINETIKOS MEDICAL, INC.
K050468	TRIABSORB COMPOSITE SCREW	Aug 31, 2005	Substantially Equivalent	ADVANCED BIOMATERIALS
K052080	MATRYX INTERFERENCE SCREW	Aug 25, 2005	Substantially Equivalent	LINVATEC BIOMATERIALS, INC.
K051310	PLC SCREW	Jul 26, 2005	Substantially Equivalent	SMITH & NEPHEW, INC.
K051309	ROI FUSION RODS & PLATES	Jul 11, 2005	Substantially Equivalent	REILEY ORTHOPAEDICS, INC.
K051323	MERETE TWISTCUT SNAP-OFF BONE SCREW	Jul 07, 2005	Substantially Equivalent	MERETE MEDICAL GMBH
K051098	PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES	Jul 07, 2005	Substantially Equivalent	ZIMMER, INC.
K043176	ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM	Jun 17, 2005	Substantially Equivalent	ARC SURGICAL LLC.
K050767	STERLING INTERFERENCE SCREW ST	Jun 09, 2005	Substantially Equivalent	REGENERATION TECHNOLOGIES, INC.
K050924	MERETE DUOTHREADTM BONE SCREW	May 27, 2005	Substantially Equivalent	MERETE MEDICAL GMBH
K050754	PRECIMED CANNULATED SCREW SYSTEM	May 18, 2005	Substantially Equivalent	PRECIMED, INC.
K050749	ARTHREX TAK FAMILY	May 12, 2005	Substantially Equivalent	ARTHREX, INC.
K050683	SYNTHES (USA) 3.5MM CONICAL SCREWS	Apr 27, 2005	Substantially Equivalent	SYNTHES (USA)
K050636	SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS	Apr 21, 2005	Substantially Equivalent	SYNTHES (USA)
K050358	ARTHERX CORKSCREW FT II SUTURE ANCHOR	Apr 15, 2005	Substantially Equivalent	ARTHREX, INC.
K050819	CHARLOTTE SNAP-OFF SCREW	Apr 11, 2005	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K050497	BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET	Mar 25, 2005	Substantially Equivalent	LINVATEC CORP.
K050634	MODIFICATION TO: ARTHREX V-TAK	Mar 21, 2005	Substantially Equivalent	ARTHREX, INC.
K050346	STABILIZATION SCREW	Mar 17, 2005	Substantially Equivalent	NEWDEAL S.A.
K043410	EPIPHYSIS SCREW	Feb 24, 2005	Substantially Equivalent	I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
K043142	INION OTPS BIODEGRADABLE MINI PLATING SYSTEM	Feb 18, 2005	Substantially Equivalent	INION LTD.
K050226	ASIAN INTRAMEDULLARY HIP SCREW NAILS	Feb 11, 2005	Substantially Equivalent	SMITH & NEPHEW, INC.
K043185	SYNTHES 3.5MM CORTEX SCREWS	Feb 03, 2005	Substantially Equivalent	SYNTHES (USA)
K043583	CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003	Jan 26, 2005	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K043102	MULTI-USE COMPRESSION SCREW	Jan 21, 2005	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K043281	CHARLOTTE HIGH-DEMAND COMPRESSION SCREW	Jan 19, 2005	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K042079	OSS/(SCARF)- AND OSW-SCREW	Dec 20, 2004	Substantially Equivalent	O.M.T. OBERFLACHEN-UND MATERIALTECHNOLOGIE GMBH
K043337	ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR	Dec 14, 2004	Substantially Equivalent	ARTHREX, INC.
K042584	OPUS MINIMAGNUM ANCHOR WITH INSERTER	Dec 14, 2004	Substantially Equivalent	OPUS MEDICAL, INC.
K042552	BIO-CORE INTERFERENCE SCREW	Dec 14, 2004	Substantially Equivalent	BIOMET, INC.
K032830	PLLA CANNULATED INTERFERENCE SCREW	Dec 14, 2004	Substantially Equivalent	ADVANCED BIOMATERIALS
K041075	FASTIN RC ANCHOR	Nov 09, 2004	Substantially Equivalent	DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
K041069	SPIRALOK ANCHOR	Nov 09, 2004	Substantially Equivalent	DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
K042796	ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE	Nov 05, 2004	Substantially Equivalent	COAPT SYSTEMS, INC.
K042778	BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE	Nov 04, 2004	Substantially Equivalent	LINVATEC CORP.
K041356	ARTHREX TENODESIS SCREW FAMILY	Nov 04, 2004	Substantially Equivalent	ARTHREX, INC.
K041189	ARTHREX TRIMIT FAMILY	Nov 04, 2004	Substantially Equivalent	ARTHREX, INC.
K041961	SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM	Oct 20, 2004	Substantially Equivalent	SCANDIUS BIOMEDICAL, INC.
K042356	SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS	Oct 07, 2004	Substantially Equivalent	SYNTHES (USA)
K041835	ENDOTINE MIDFACE B 4.5 DEVICE	Sep 28, 2004	Substantially Equivalent	COAPT SYSTEMS, INC.
K042310	ORTHO-PRO CANNULATED BONE SCREWS	Sep 16, 2004	Substantially Equivalent	ORTHO-PRO LLC
K042295	SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020	Sep 16, 2004	Substantially Equivalent	LINVATEC BIOMATERIALS, LTD.
K042244	BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE	Sep 16, 2004	Substantially Equivalent	TRIAGE MEDICAL, INC.
K042030	HYPROCURE SUBTALAR IMPLANT SYSTEM	Sep 16, 2004	Substantially Equivalent	GRAHAM MEDICAL TECHNOLOGIES, L.L.C.
K041936	BIOPRO SUBTALAR IMPLANT	Sep 08, 2004	Substantially Equivalent	BIOPRO, INC.
K041749	SCANDIUS ACL RECONSTRUCTION SYSTEM	Sep 08, 2004	Substantially Equivalent	SCANDIUS BIOMEDICAL, INC.
K041533	SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS	Sep 01, 2004	Substantially Equivalent	SYNTHES (USA)
K042078	ENDOTINE FOREHEAD TRIPLE DEVICE	Aug 27, 2004	Substantially Equivalent	COAPT SYSTEMS, INC.
K041456	SNAP-OFF SCREWS	Aug 25, 2004	Substantially Equivalent	FOURNITURES HOSPITALIERES INDUSTRIE
K040542	SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW	Aug 19, 2004	Substantially Equivalent	SMITH & NEPHEW, INC.
K031714	INION TRINION BIODEGRADABLE MENISCUS SCREW	Aug 16, 2004	Substantially Equivalent	INION LTD.
K041289	TALUS OF VILEX (TOV)	Aug 05, 2004	Substantially Equivalent	VILEX, INC.
K041287	VILEX BONE PLATE SYSTEM	Aug 05, 2004	Substantially Equivalent	VILEX, INC.
K041274	RESORBABLE INTERFERENCE SCREW	Jul 28, 2004	Substantially Equivalent	ARTHROTEK, INC.
K033355	LACTOSCREW SCREW ANCHOR	Jun 30, 2004	Substantially Equivalent	BIOMET ORTHOPEDICS, INC.
K031939	BIO-EUROLIG INTERFERENCE SCREW	Jun 24, 2004	Substantially Equivalent	FOURNITURES HOSPITALIERES INDUSTRIE
K040701	SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS	Jun 15, 2004	Substantially Equivalent	SYNTHES (USA)
K040265	LITTLE GRAFTER SCREW	May 28, 2004	Substantially Equivalent	BIOCOMPOSITES LTD.
K040656	MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW	May 25, 2004	Substantially Equivalent	SMITH & NEPHEW, INC.
K040475	MICROMAX SUTURE ANCHOR	May 21, 2004	Substantially Equivalent	BIOMET, INC.
K040740	ENDOTINE TRANSBLEPH DEVICE	May 10, 2004	Substantially Equivalent	COAPT SYSTEMS, INC.
K032894	OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,	May 07, 2004	Substantially Equivalent	LINVATEC BIOMATERIALS, INC.
K032447	CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED	Apr 16, 2004	Substantially Equivalent	LINVATEC BIOMATERIALS, LTD.
K040331	SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS	Apr 14, 2004	Substantially Equivalent	SMITH & NEPHEW, INC.
K040594	HERCULON SOFT TISSUE REATTACHMENT SYSTEM	Mar 31, 2004	Substantially Equivalent	UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K032717	BIOCRYL RAPIDE INTERFERENCE SCREW	Mar 31, 2004	Substantially Equivalent	MITEK WORLDWIDE
K040356	KOMPRESSOR SCREW SYSTEM	Mar 01, 2004	Substantially Equivalent	KINETIKOS MEDICAL, INC.
K033975	SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS	Mar 01, 2004	Substantially Equivalent	SYNTHES (USA)
K033792	BILOK ST SCREW	Mar 01, 2004	Substantially Equivalent	BIOCOMPOSITES LTD.
K033749	TITANIUM CANNULATED INTERFERENCE SCREW	Feb 23, 2004	Substantially Equivalent	ADVANCED BIOMATERIALS
K033639	ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM	Jan 15, 2004	Substantially Equivalent	ACUMED LLC
K032966	THE ANSWER SCREW SUPPLEMENTATION SYSTEM	Jan 13, 2004	Substantially Equivalent	SIMPLICITY ORTHOPEDIC SOLUTIONS, LLC
K033804	BIOANCHOR WITH DISPOSABLE DRIVER	Dec 31, 2003	Substantially Equivalent	LINVATEC CORP.
K033524	COAPT ENDOTINE CHIN 3.5 DEVICE	Dec 18, 2003	Substantially Equivalent	COAPT SYSTEMS, INC.
K033740	LORENZ STERNAL CLOSURE SYSTEM	Dec 15, 2003	Substantially Equivalent	WALTER LORENZ SURGICAL, INC.
K032902	SUBTALAR ARTHRORISIS IMPLANT	Dec 15, 2003	Substantially Equivalent	NEXA ORTHOPEDICS, INC.
K033252	MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM	Nov 13, 2003	Substantially Equivalent	Stryker Endoscopy
K033233	LACTOSORB TIBIAL L-15 SCREW AND WASHER	Nov 05, 2003	Substantially Equivalent	BIOMET, INC.
K032682	STS SCREW	Oct 22, 2003	Substantially Equivalent	ORTHO-PRO LLC
K032167	BIO-INTRAFIX TIBIAL SCREW AND SHEATH	Oct 15, 2003	Substantially Equivalent	MITEK WORLDWIDE
K032770	ENDOTINE FOREHEAD DEVICE	Oct 08, 2003	Substantially Equivalent	COAPT SYSTEMS, INC.
K032098	ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B	Oct 07, 2003	Substantially Equivalent	ARTHREX, INC.
K032072	LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE	Oct 01, 2003	Substantially Equivalent	ARTHROTEK, INC.
K031945	ARTHREX TRIMIT SCREW, MODEL AR-4161B	Sep 22, 2003	Substantially Equivalent	ARTHREX, INC.
K031937	ALANTECH GRAFT FIXATION SCREW	Sep 04, 2003	Substantially Equivalent	ARTHROCARE CORP.
K031155	OSTEOMED SUBTALAR IMPLANT SYSTEM	Aug 22, 2003	Substantially Equivalent	OSTEOMED L.P.
K032228	LORENZ 2.4 SELF DRILLING SCREWS	Aug 11, 2003	Substantially Equivalent	WALTER LORENZ SURGICAL, INC.
K032224	BIORCI SCREW	Aug 08, 2003	Substantially Equivalent	SMITH & NEPHEW, INC.
K030302	HBS HEADLESS BONE SCREW	Aug 08, 2003	Substantially Equivalent	SCHOENING & ASSOC., INC.
K031050	PCW PERCUTANEOUS COMPRESSION WIRE	Jul 14, 2003	Substantially Equivalent	MILLENNIUM MEDICAL TECHNOLOGIES, INC.
K031685	TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318	Jul 01, 2003	Substantially Equivalent	SMITH & NEPHEW, INC.
K031751	RAPIDFIRE SELF DRILLING SCREWS	Jun 26, 2003	Substantially Equivalent	WALTER LORENZ SURGICAL, INC.
K030995	MINILOK QUICKANCHOR PLUS	Jun 26, 2003	Substantially Equivalent	MITEK WORLDWIDE
K030900	INION OTPS BIODEGRADABLE FIXATON SYSTEM	Jun 19, 2003	Substantially Equivalent	INION LTD.
K030848	PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX	Jun 02, 2003	Substantially Equivalent	KARL STORZ ENDOSCOPY
K023887	INION OTPS BIODEGRADABLE MINI PLATING SYSTEM	May 30, 2003	Substantially Equivalent	INION LTD.
K030388	IMPACT SUTURE ANCHOR. MODEL 433510	Apr 24, 2003	Substantially Equivalent	BIONX IMPLANTS, LTD.
K023365	LEFORTE SYSTEM BONE SCREW	Apr 18, 2003	Substantially Equivalent	JEIL MEDICAL CORPORATION
K030706	EBI DYNAFIX COMPRESSION BONE SCREW	Mar 20, 2003	Substantially Equivalent	EBI, L.P.
K030368	KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW	Mar 20, 2003	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K023192	STRYKER BIOZIP SUTURE ANCHOR	Mar 20, 2003	Substantially Equivalent	Stryker Endoscopy
K024115	MICROFIX QUICKANCHOR PLUS	Mar 13, 2003	Substantially Equivalent	MITEK WORLDWIDE
K023013	STRYKER XCEL ANCHOR SYSTEM	Feb 26, 2003	Substantially Equivalent	Stryker Endoscopy
K024233	KOMPRESSOR SCREW SYSTEM	Feb 06, 2003	Substantially Equivalent	KINETIKOS MEDICAL, INC.
K024086	PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM	Jan 09, 2003	Substantially Equivalent	BIOMET ORTHOPEDICS, INC.
K024060	MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM	Dec 20, 2002	Substantially Equivalent	HOWMEDICA OSTEONICS CORP.
K023922	COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197	Dec 20, 2002	Substantially Equivalent	COAPT SYSTEMS, INC.
K021233	AAP CANNULATED SCREWS	Dec 09, 2002	Substantially Equivalent	AAP IMPLANTATE AG
K022952	MODULAR HEAD BONE SCREW	Dec 02, 2002	Substantially Equivalent	BIOMET, INC.
K023260	1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM	Oct 18, 2002	Substantially Equivalent	OSTEOMED CORP.
K021351	BIOSTEON CROSS PIN	Oct 17, 2002	Substantially Equivalent	BIOCOMPOSITES LTD.
K023294	BOSWORTH CORACO-CLAVICULAR SCREW	Oct 09, 2002	Substantially Equivalent	HOWMEDICA OSTEONICS CORP.
K023022	NUGEN FX SCREW	Oct 04, 2002	Substantially Equivalent	BIONX IMPLANTS, INC.
K023021	MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T	Oct 04, 2002	Substantially Equivalent	SMITH & NEPHEW, INC.
K022234	ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B	Oct 03, 2002	Substantially Equivalent	ARTHREX, INC.
K022981	INION CPS 2.5/2.8 SCREW	Sep 12, 2002	Substantially Equivalent	INION LTD.
K022726	STAYFUSE GT-IP	Sep 06, 2002	Substantially Equivalent	PIONEER SURGICAL TECHNOLOGY
K021932	SYNTHES 6.5 MM CANNULATED SCREW	Sep 06, 2002	Substantially Equivalent	SYNTHES (USA)
K022647	HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM	Sep 05, 2002	Substantially Equivalent	TRIAD MEDICAL, INC.
K021662	MAGLY 6.5MM CANNULATED SCREWS	Aug 12, 2002	Substantially Equivalent	MAGLY ORTHOPEDICS, LLC
K021579	MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM	Aug 09, 2002	Substantially Equivalent	MAGLY ORTHOPEDICS, LLC
K021556	SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW	Aug 09, 2002	Substantially Equivalent	SYNTHES (USA)
K020222	WISORB MALLEOLAR SCREW	Jul 29, 2002	Substantially Equivalent	CAMBRIDGE SCIENTIFIC, INC.
K021280	INION HEXALON BIODEGRADABLE ACL/PCL SCREW	Jul 17, 2002	Substantially Equivalent	INION LTD.
K021254	LACTOSORB MINI INTERFERENCE SCREW	Jul 17, 2002	Substantially Equivalent	BIOMET ORTHOPEDICS, INC.
K021883	BIOFASTIN RC THREADED SUTURE ANCHOR	Jul 01, 2002	Substantially Equivalent	MITEK WORLDWIDE
K021828	SMALL HAMMER TOE PIN	Jul 01, 2002	Substantially Equivalent	BIOMET, INC.
K021832	ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER	Jun 26, 2002	Substantially Equivalent	BIOMET, INC.
K020056	DUET SUTURE ANCHOR	Jun 26, 2002	Substantially Equivalent	BIONX IMPLANTS, LTD.
K021030	TITANIUM CANNULATED INTERFERENCE SCREW	Jun 25, 2002	Substantially Equivalent	FUTURE MEDICAL SYSTEMS, INC.
K013131	BIOSCREW XTRALOK	Jun 11, 2002	Substantially Equivalent	LINVATEC CORP.
K020791	HBS HEADLESS BONE SCREW	Jun 06, 2002	Substantially Equivalent	MILLENNIUM MEDICAL TECHNOLOGIES, INC.
K020377	PRE-LOADED BIOSTINGER HORNET	May 06, 2002	Substantially Equivalent	LINVATEC CORP.
K020043	4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B	Apr 02, 2002	Substantially Equivalent	ARTHREX, INC.
K014304	BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S	Mar 27, 2002	Substantially Equivalent	TRIAGE MEDICAL INC
K020159	SMITH & NEPHEW TWINFIX TI QUICK T	Mar 26, 2002	Substantially Equivalent	SMITH & NEPHEW, INC.
K014243	BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050	Mar 26, 2002	Substantially Equivalent	TRIAGE MEDICAL INC
K014154	VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00	Mar 18, 2002	Substantially Equivalent	VILEX, INC.
K014153	COAPT SYSTMES ENDOTINE DEVICE	Mar 15, 2002	Substantially Equivalent	COAPT SYSTEMS, INC.
K013572	MITEK BIOCRYL INTERFERENCE SCREWS	Mar 14, 2002	Substantially Equivalent	MITEK PRODUCTS
K020446	MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM	Mar 13, 2002	Substantially Equivalent	AMERICAN MEDICAL SYSTEMS, INC.
K013954	LORENZ SELF DRILLING SCREWS	Feb 28, 2002	Substantially Equivalent	WALTER LORENZ SURGICAL, INC.
K020352	SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE	Feb 26, 2002	Substantially Equivalent	UNITED STATES SURGICAL
K013107	BIOABSORBABLE INTERFERENCE SCREW MEGAFIX	Feb 26, 2002	Substantially Equivalent	KARL STORZ ENDOSCOPY
K020266	INION CPS BSSO SCREW	Feb 22, 2002	Substantially Equivalent	INION LTD.
K014185	AOS CANNULATED BONE SCREW SYSTEM	Feb 13, 2002	Substantially Equivalent	ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
K013685	PLLA CANNULATED INTERFERENCE SCREW	Jan 18, 2002	Substantially Equivalent	FUTURE MEDICAL SYSTEMS, INC.
K013903	HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2	Dec 17, 2001	Substantially Equivalent	TRIAD MEDICAL, INC.
K013786	DRG ORTHOHEX SS BONE SCREW	Dec 17, 2001	Substantially Equivalent	DOCTOR'S RESEARCH GROUP, INC.
K013534	SELF-COUNTERSINKING BONE SCREW	Dec 17, 2001	Substantially Equivalent	BIOMET ORTHOPEDICS, INC.
K013890	SURGICAL DYNAMICS MENISCAL STAPLE	Dec 11, 2001	Substantially Equivalent	UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K011451	REUNITE FUSION SCREW	Dec 10, 2001	Substantially Equivalent	BIOMET, INC.
K013044	SYNTHES 3.9 MM PELVIC SCREWS	Dec 03, 2001	Substantially Equivalent	SYNTHES (USA)
K012945	SYNTHES 2.4 MM CANNULATED SCREW	Dec 03, 2001	Substantially Equivalent	SYNTHES (USA)
K012572	SOFT TISSUE SCREW AND WASHER	Dec 03, 2001	Substantially Equivalent	BIOMET, INC.
K012469	RESORBABLE NO PROFILE SCREW AND WASHER	Dec 03, 2001	Substantially Equivalent	BIOMET MANUFACTURING, INC.
K013546	MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214	Nov 21, 2001	Substantially Equivalent	BIONX IMPLANTS, INC.
K012872	RESORBABLE SCREW ANCHOR	Nov 20, 2001	Substantially Equivalent	ARTHROTEK, INC.
K012818	HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX	Nov 20, 2001	Substantially Equivalent	TRIAGE MEDICAL INC
K012817	HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED	Nov 20, 2001	Substantially Equivalent	TRIAGE MEDICAL INC
K012798	INTEX SCREW	Nov 16, 2001	Substantially Equivalent	BIOMET, INC.
K011821	MODIFICATION TO THE I.C.O.S SCREW	Sep 06, 2001	Substantially Equivalent	NEWDEAL S.A.
K011946	THE SPIN SNAP-OFF SCREW	Aug 24, 2001	Substantially Equivalent	NEW DEAL, S.A.
K012280	TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2	Aug 17, 2001	Substantially Equivalent	TRIAGE MEDICAL INC
K011102	ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM	Aug 03, 2001	Substantially Equivalent	AESCULAP, INC.
K010738	CANNULATED PLUS SCREW SYSTEM	Aug 01, 2001	Substantially Equivalent	ORTHOMATRIX, INC.
K012001	SMARTSCREW	Jul 18, 2001	Substantially Equivalent	BIONX IMPLANTS, LTD.
K012000	1.5MM BONE FIXATION KIT	Jul 18, 2001	Substantially Equivalent	BIONX IMPLANTS, LTD.
K011910	IN-FAST BONE SCREW SYSTEM	Jul 13, 2001	Substantially Equivalent	AMERICAN MEDICAL SYSTEMS, INC.
K010964	AUTO-DRIVE LAG SCREW SYSTEM	Jul 05, 2001	Substantially Equivalent	OSTEOMED CORP.
K011719	PLUS CANCELLOUS BONE SCREWS	Jul 02, 2001	Substantially Equivalent	PLUS ORTHOPEDICS
K010884	TITANIUM COMPRESSION ANCHOR SYSTEM	Jun 20, 2001	Substantially Equivalent	ANCHOR MEDICAL TECHNOLOGIES
K011262	MODIFICATION TO THE BOLD SCREW	Jun 15, 2001	Substantially Equivalent	NEWDEAL S.A.
K010783	2.0/2.4 CANNULATED SCREW SYSTEM	May 30, 2001	Substantially Equivalent	OSTEOMED CORP.
K010594	DJ ORTHOPEDICS POST SCREW	May 29, 2001	Substantially Equivalent	DJ ORTHOPEDICS, LLC
K010554	MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A	May 25, 2001	Substantially Equivalent	BIONX IMPLANTS, INC.
K010525	ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM	May 23, 2001	Substantially Equivalent	ARTHREX, INC.
K010633	RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM	May 09, 2001	Substantially Equivalent	MITEK PRODUCTS
K010595	DJ ORTHOPEDICS INTERFERENCE SCREW	May 08, 2001	Substantially Equivalent	DJ ORTHOPEDICS, LLC
K003077	SMARTSCREW MODEL 222006...227510	Apr 26, 2001	Substantially Equivalent	BIONX IMPLANTS, LTD.
K001581	LACTOSORB 5.0 MM WASHER	Mar 20, 2001	Substantially Equivalent	BIOMET, INC.
K003816	ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM	Mar 09, 2001	Substantially Equivalent	ARTHREX, INC.
K002274	SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW	Mar 07, 2001	Substantially Equivalent	SMITH & NEPHEW, INC.
K003700	SYNTHES HAMSTRING LOOP	Feb 20, 2001	Substantially Equivalent	SYNTHES (USA)
K003599	SMITH & NEPHEW SUTURE ANCHOR	Feb 15, 2001	Substantially Equivalent	SMITH & NEPHEW, INC.
K003641	BIOLOK SCREW, BIOSTEON SCREW	Feb 08, 2001	Substantially Equivalent	BIOCOMPOSITES LTD.
K002654	HOWMEDICA OSTEONICS SHOULDER SCREW	Sep 22, 2000	Substantially Equivalent	HOWMEDICA OSTEONICS CORP.
K002271	2.4MM CORTEX SCREW, SELF-TAPPING	Aug 25, 2000	Substantially Equivalent	SYNTHES (USA)
K002070	BIOLOK SCREW	Aug 25, 2000	Substantially Equivalent	BIOCOMPOSITES LTD.
K993166	STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM	Aug 04, 2000	Substantially Equivalent	Stryker Endoscopy
K001231	THE KALIX IMPLANT	Jul 11, 2000	Substantially Equivalent	NEWDEAL S.A.
K993630	BIOLOK SCREW	Apr 26, 2000	Substantially Equivalent	ENCORE ORTHOPEDICS, INC.
K000080	ASNIS III CANNULATED SCREW SYSTEM	Apr 03, 2000	Substantially Equivalent	HOWMEDICA OSTEONICS CORP.
K994382	NONLINEAR TAPER LAG SCREW	Mar 10, 2000	Substantially Equivalent	THEKEN SURGICAL
K994152	THE LIGAMENT ANCHOR SOFT SCREW	Mar 06, 2000	Substantially Equivalent	CORIN U.S.A.
K994202	ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM	Feb 25, 2000	Substantially Equivalent	SMITH & NEPHEW, INC.
K993762	I.CO.S SCREW	Feb 04, 2000	Substantially Equivalent	NEWDEAL S.A.
K000089	SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS	Feb 03, 2000	Substantially Equivalent	SYNTHES (USA)
K992396	BIORCI SCREW	Jan 12, 2000	Substantially Equivalent	SMITH & NEPHEW ENDOSCOPY, INC.
K993975	ABSOLUTE ABSORBABLE INTERFERENCE SCREW	Dec 20, 1999	Substantially Equivalent	INNOVASIVE DEVICES, INC.
K991964	EIS THREADED SCREW FRACTURE FIXATION	Dec 20, 1999	Substantially Equivalent	GROUPE LEPINE
K992945	RCI FIXATION SCREWS (WITH ASSORTED SIZES)	Nov 18, 1999	Substantially Equivalent	SMITH & NEPHEW, INC.
K991024	BONE BULLET SUTURE ANCHOR	Nov 16, 1999	Substantially Equivalent	LINVATEC CORP.
K993025	MODIFICATION TO BONE MULCH SCREW SYSTEM	Oct 08, 1999	Substantially Equivalent	BIOMET, INC.
K992367	EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS	Sep 23, 1999	Substantially Equivalent	ELECTRO-BIOLOGY, INC.
K992611	MITEK ROTATOR CUFF QUICKANCHOR PLUS	Sep 22, 1999	Substantially Equivalent	MITEK PRODUCTS
K992947	CANNULATED SMARTSCREW MODELS 224540C, 224570C	Sep 21, 1999	Substantially Equivalent	BIONX IMPLANTS, LTD.
K992487	MITEK MINI QUICKANCHOR PLUS	Sep 21, 1999	Substantially Equivalent	MITEK PRODUCTS
K992106	MODUS SYSTEM SELF-DRILLING SCREWS	Sep 17, 1999	Substantially Equivalent	MEDARTIS AG
K990194	BIOBUTTON	Sep 17, 1999	Substantially Equivalent	LINVATEC CORP.
K992301	REUNITE SCREWS	Sep 01, 1999	Substantially Equivalent	BIOMET MANUFACTURING, INC.
K992277	STAPLETAC BONE ANCHOR SYSTEM	Jul 30, 1999	Substantially Equivalent	INFLUENCE, INC.
K990770	BIORC ANCHOR	Jul 30, 1999	Substantially Equivalent	LINVATEC CORP.
K991477	SPIN SNAP-OFF SCREW	Jul 14, 1999	Substantially Equivalent	NEWDEAL S.A.
K990454	BIO-INTERFERENCE SCREW	Jul 01, 1999	Substantially Equivalent	INNOVASIVE DEVICES, INC.
K990351	BONE SCREWS	Jun 01, 1999	Substantially Equivalent	BREGMA INTERNATIONAL TRADING COMPANY LTD.
K991298	BONE MULCH SCREW SYSTEM	May 14, 1999	Substantially Equivalent	BIOMET, INC.
K990804	STAYFUSE	Apr 29, 1999	Substantially Equivalent	PIONEER SURGICAL TECHNOLOGY
K990776	AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM	Apr 29, 1999	Substantially Equivalent	AAP IMPLANTATE AG
K990622	BOLD SCREW	Apr 29, 1999	Substantially Equivalent	NEWDEAL S.A.
K991197	VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24	Apr 26, 1999	Substantially Equivalent	VILEX, INC.
K991151	VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREW	Apr 26, 1999	Substantially Equivalent	VILEX, INC.
K990513	ULTIMAX CORTICAL BONE SCREWS	Mar 17, 1999	Substantially Equivalent	BIODYNAMIC TECHNOLOGIES, INC.
K990019	DRG MEDIUM SCREW SYSTEM	Mar 15, 1999	Substantially Equivalent	DOLPHIN MEDICAL TECHNOLOGIES, INC.
K984209	STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED	Feb 03, 1999	Substantially Equivalent	BIOMET, INC.
K984320	BIOABSORBABLE INTERFERENCE SCREWS	Jan 28, 1999	Substantially Equivalent	SMITH & NEPHEW, INC.
K983592	SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS	Jan 28, 1999	Substantially Equivalent	SULZER ORTHOPEDICS, INC.
K984331	ODI ULTIMATE COMPRESSION HIP SCREW	Jan 20, 1999	Substantially Equivalent	ORTHOPEDIC DESIGNS, INC.
K970829	PHUSIS ABSORBABLE INTERFERENCE SCREW	Dec 22, 1998	Substantially Equivalent	TORNIER
K983495	SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420	Dec 16, 1998	Substantially Equivalent	SYNTEC SCIENTIFIC CORP.
K983508	OSTEO COMPRESSION CONDYLE SCREW SYSTEM	Dec 07, 1998	Substantially Equivalent	OSTEONICS CORP.
K983165	OSTEO 4.0MM CANNULATED SCREW SYSTEM	Dec 03, 1998	Substantially Equivalent	OSTEONICS CORP.
K983006	OSTEO 5.0MM CANNULATED SCREW SYSTEM	Nov 23, 1998	Substantially Equivalent	STRYKER OSTEONICS
K982662	DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW	Oct 28, 1998	Substantially Equivalent	DEPUY ORTHOPAEDICS, INC.
K982497	ARTHROTEK INTERFERENCE SCREW	Oct 16, 1998	Substantially Equivalent	BIOMET, INC.
K980457	ENDO ABSORBABLE INTERFERENCE SCREW	Sep 08, 1998	Substantially Equivalent	ENDO SURGICAL CONCEPTS, INC.
K982222	SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM	Jul 29, 1998	Substantially Equivalent	SYNTHES (USA)
K981187	ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001	Jul 01, 1998	Substantially Equivalent	ARTHREX, INC.
K961320	CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM	Jun 25, 1998	Substantially Equivalent	BUCKMAN CO., INC.
K981670	DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW	Jun 22, 1998	Substantially Equivalent	DEPUY, INC.
K980841	RCI FIXATION SCREWS	May 20, 1998	Substantially Equivalent	SMITH & NEPHEW, INC.
K981372	SYNTHES 3.0 MM PC-FIX SYSTEM	May 11, 1998	Substantially Equivalent	SYNTHES (USA)
K981259	OSTEO 4.0MM CANNULATED SCREW SYSTEM	May 11, 1998	Substantially Equivalent	OSTEONICS CORP.
K980681	INNOVASIVE DEVICES MENISCAL SCREW	Apr 29, 1998	Substantially Equivalent	INNOVASIVE DEVICES, INC.
K980364	HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS	Apr 29, 1998	Substantially Equivalent	HOWMEDICA CORP.
K980440	DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW	Apr 03, 1998	Substantially Equivalent for Some Indications	DEPUY, INC.
K972919	BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW	Mar 27, 1998	Substantially Equivalent	BIONX IMPLANTS, INC.
K974785	AUTO-DRIVE BONE SCREW	Mar 18, 1998	Substantially Equivalent	OSTEOMED CORP.
K974756	BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS	Mar 12, 1998	Substantially Equivalent for Some Indications	BIODYNAMIC TECHNOLOGIES, INC.
K974538	MENISCAL REPAIR DEVICE	Mar 03, 1998	Substantially Equivalent	LINVATEC CORP.
K973758	BIOSCREW ABSORBABLE INTERFERENCE SREW	Feb 27, 1998	Substantially Equivalent	LINVATEC CORP.
K972722	ULTIMATE COMPRESSION SCREW SYSTEM	Jan 23, 1998	Substantially Equivalent for Some Indications	ORTHOPEDIC DESIGNS, INC.
K973309	VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW	Jan 16, 1998	Substantially Equivalent for Some Indications	VILEX, INC.
K973810	DRG LARGE SCREW SYSTEM	Jan 05, 1998	Substantially Equivalent for Some Indications	DOLPHIN MEDICAL TECHNOLOGIES, INC.
K972217	ORTHOPEDIC SCREW SYSTEM	Nov 20, 1997	Substantially Equivalent	FERGUSON MEDICAL
K973005	THE CORIFIX LIGAMENT ANCHOR	Nov 10, 1997	Substantially Equivalent	CORIN U.S.A.
K973586	SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II	Nov 07, 1997	Substantially Equivalent for Some Indications	SPINAL CONCEPTS, INC.
K972494	DEPUY DUPONT ABSORBABLE SET SCREW	Oct 01, 1997	Substantially Equivalent	DEPUY, INC.
K970912	LEIBINGER SELF-DRILLING SCREW	Oct 01, 1997	Substantially Equivalent	HOWMEDICA LEIBINGER, INC.
K972599	ACUFEX SCREW CANNULA	Sep 19, 1997	Substantially Equivalent	SMITH & NEPHEW ENDOSCOPY, INC.
K972403	BTI CORTICAL BONE SCREWS	Aug 29, 1997	Substantially Equivalent	BIODYNAMIC TECHNOLOGIES, INC.
K972233	STRYKER WEDGE INTERFERENCE SCREW SYSTEM	Aug 05, 1997	Substantially Equivalent	Stryker Endoscopy
K971800	OSTEO CANNULATED SCREW SYSTEM	Jul 30, 1997	Substantially Equivalent	OSTEONICS CORP.
K971654	OSTEO COMPRESSION HIP SCREW SYSTEM	Jul 09, 1997	Substantially Equivalent	OSTEONICS CORP.
K971070	SCARF THREAD-HEAD (TM) HEAD SCREW	Jul 09, 1997	Substantially Equivalent	LANDOS, INC.
K971069	TWIST-OFF (TM) SCREW	Jul 09, 1997	Substantially Equivalent	LANDOS, INC.
K971068	34MM SCARF THREAD-HEAD(TM) SCREW	Jul 09, 1997	Substantially Equivalent	LANDOS, INC.
K971778	OSTEO SMALL AND MINI BONE SCREWS	Jun 27, 1997	Substantially Equivalent	OSTEONICS CORP.
K970929	DEPUY LOW PROFILE BONE SCREW	Jun 09, 1997	Substantially Equivalent for Some Indications	DEPUY, INC.
K970549	TITANIUM ALLOY BONE SCREWS	Apr 30, 1997	Substantially Equivalent for Some Indications	AESCULAP, INC.
K964970	BIOMET BONE SCREW	Apr 03, 1997	Substantially Equivalent	BIOMET, INC.
K965073	9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW	Feb 27, 1997	Substantially Equivalent	SMITH & NEPHEW, INC.
K963937	NORTHWEST PRECISION TECHNOLOGIES 6.5 MM CANNULATED CANNULATED CANCELLOUS SCREW	Jan 22, 1997	Substantially Equivalent for Some Indications	NORTHWEST PRECISION TECHNOLOGIES
K963739	LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS	Jan 22, 1997	Substantially Equivalent for Some Indications	HOWMEDICA LEIBINGER, INC.
K955733	HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED)	Nov 18, 1996	Substantially Equivalent	DEPUY, INC.
K963350	DEPUY MOTECH PEAK FIXATION SYSTEM	Nov 14, 1996	Substantially Equivalent	DEPUY, INC.
K960652	BIOSCREW ABSORBABLE INTERFERENCE SCREW	Nov 14, 1996	Substantially Equivalent for Some Indications	LINVATEC CORP.
K962706	EZ-FIX CANNULATED SCREW SYSTEM	Nov 13, 1996	Substantially Equivalent	BIODYNAMIC TECHNOLOGIES, INC.
K963192	SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS	Nov 08, 1996	Substantially Equivalent for Some Indications	SYNTHES (USA)
K963172	SYNTHES STERILE 4.5 MM CANNULATED SCREWS	Nov 08, 1996	Substantially Equivalent for Some Indications	SYNTHES (USA)
K962987	EZ-FIX SMALL CANNULATED SCREW SYSTEM	Nov 04, 1996	Substantially Equivalent	BIODYNAMIC TECHNOLOGIES, INC.
K963398	ALTA FULLY THREADED CROSS-LOCKING SCREWS	Oct 10, 1996	Substantially Equivalent	HOWMEDICA CORP.
K963118	EXTREMITY BONE SCREW	Oct 10, 1996	Substantially Equivalent for Some Indications	ACUMED, INC.
K962233	TWIST-OFF SCREW	Oct 03, 1996	Substantially Equivalent	LANDOS, INC.
K962823	SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER	Oct 01, 1996	Substantially Equivalent for Some Indications	SYNTHES (USA)
K962236	SCARF THREAD-HEAD SCREW	Sep 20, 1996	Substantially Equivalent	LANDOS, INC.
K962779	COMPRESSION SCREW	Aug 23, 1996	Substantially Equivalent for Some Indications	ORTHOPAEDIC BIOSYSTEMS, LTD.
K960962	INTERFERENCE SCREW	Aug 19, 1996	Substantially Equivalent	LINVATEC CORP.
K960940	BIOSCREW ABSORBABLE INTERFERENCE SCREW	Aug 15, 1996	Substantially Equivalent	LINVATEC CORP.
K961413	SYNTHES ANATOMICAL LOCKING PLATE SYSTEM	Aug 07, 1996	Substantially Equivalent	SYNTHES (USA)
K961905	MEDICINELODGE, INC. SET SCREW	Aug 06, 1996	Substantially Equivalent	MEDICINE LODGE, INC.
K962011	SYNTHES 7.0/7.3 MM CANNULATED SCREWS	Aug 05, 1996	Substantially Equivalent for Some Indications	SYNTHES (USA)
K960692	SUBTALAR MBA SYSTEM	Jul 23, 1996	Substantially Equivalent	KINETIKOS MEDICAL, INC.
K961649	ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER	Jul 16, 1996	Substantially Equivalent for Some Indications	SMITH & NEPHEW ENDOSCOPY, INC.
K961234	DEPUY ADVANTAGE FIXATION SCREW SYSTEM	Jun 19, 1996	Substantially Equivalent	DEPUY, INC.
K960704	DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS	Jun 06, 1996	Substantially Equivalent	DEPUY, INC.
K961157	WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW	May 17, 1996	Substantially Equivalent for Some Indications	WHITESIDE BIOMECHANICS, INC.
K960537	K2 BONE SCREW SYSTEM	Mar 25, 1996	Substantially Equivalent for Some Indications	KINETIKOS MEDICAL, INC.
K960533	K3 BONE SCREW SYSTEM	Mar 25, 1996	Substantially Equivalent for Some Indications	KINETIKOS MEDICAL, INC.
K925872	NORTHO BONE SCREW	Mar 22, 1996	Substantially Equivalent for Some Indications	NORTHO ORTHOPEDICS
K955837	CANNULATED PLUS HIP SCREW (STERILE)	Mar 04, 1996	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K955710	J.B.S. T.T.A SCREW	Mar 04, 1996	Substantially Equivalent for Some Indications	J.B.S. (USA), INC.
K954246	ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW	Feb 15, 1996	Substantially Equivalent for Some Indications	ACUFEX MICROSURGICAL, INC.
K953350	MLI INTERFERENCE SCREW	Jan 30, 1996	Substantially Equivalent for Some Indications	MEDICINE LODGE, INC.
K954757	FIXANO D.D.S. (DOUBLE SLIDING SCREW)	Jan 25, 1996	Substantially Equivalent	FERGUSON MEDICAL
K945303	ARTHREX BIOABSORBABLE INTERFERENCE SCREW	Jan 25, 1996	Substantially Equivalent	ARTHREX, INC.
K954511	GO INTRAMEDULLARY NAIL LOCKING SCREW	Dec 19, 1995	Substantially Equivalent for Some Indications	GENESIS ORTHOPEDICS, INC.
K954330	SUPER SCREW 3.5 MM	Dec 08, 1995	Substantially Equivalent	OSTEOMED CORP.
K953198	CORTICELLOUS BONE SCREW	Nov 24, 1995	Substantially Equivalent for Some Indications	HAYES MEDICAL, INC.
K953650	DEPUY STAINLESS STEEL SET SCREW	Nov 03, 1995	Substantially Equivalent for Some Indications	DEPUY, INC.
K954485	6.5MM SOLID CANCELLOUS BONE SCREW	Oct 31, 1995	Substantially Equivalent	ACE MEDICAL CO.
K952460	STRYKER ACL INTERFERENCE SCREW SYSTEM	Sep 28, 1995	Substantially Equivalent	Stryker Endoscopy
K952831	BIOSCREW ABSORBABLE INTERFERENCE SCREW	Sep 15, 1995	Substantially Equivalent	LINVATEC CORP.
K952697	TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM	Sep 12, 1995	Substantially Equivalent	SMITH & NEPHEW RICHARDS, INC.
K951232	EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM	Aug 25, 1995	Substantially Equivalent	AMERICAN MEDICAL ELECTRONICS, INC.
K952296	SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW	Aug 18, 1995	Substantially Equivalent	SYNTHES (USA)
K952272	TI. ALLOY 2.0 MM CORTEX SCREW	Jul 31, 1995	Substantially Equivalent	SYNTHES (USA)
K951389	REUNION BONE SCREW SYSTEM	Jul 24, 1995	Substantially Equivalent for Some Indications	SMITH & NEPHEW RICHARDS, INC.
K951656	NEXMED CANCELLOUS BONE SCREWS	Jul 18, 1995	Substantially Equivalent for Some Indications	NEXMED, INC.
K950875	OGDEN ANCHOR	Jul 11, 1995	Substantially Equivalent	AMERICAN MEDICAL ELECTRONICS, INC.
K946347	ABSORBABLE ACETABULAR SCREW	Jul 11, 1995	Substantially Equivalent	ZIMMER, INC.
K945525	ANSPACH SUTURE ANCHOR	Jul 11, 1995	Substantially Equivalent	THE ANSPACH EFFORT, INC.
K950833	DEPUY SET SCREW	Jul 10, 1995	Substantially Equivalent	DEPUY, INC.
K932350	ORTHOPEDIC SCREW FIXATION	Jul 05, 1995	Substantially Equivalent	OSTEOMED CORP.
K951545	OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONS	Jul 03, 1995	Substantially Equivalent	AMERICAN MEDICAL ELECTRONICS, INC.
K951493	OGDEN ANCHOR	Jul 03, 1995	Substantially Equivalent	AMERICAN MEDICAL ELECTRONICS, INC.
K951472	LMT BONE ANCHOR	Jul 03, 1995	Substantially Equivalent	LI MEDICAL TECHNOLOGIES, INC.
K951233	LMT BONE ANCHOR	Jul 03, 1995	Substantially Equivalent	LI MEDICAL TECHNOLOGIES, INC.
K943806	HARPOON SUTURE ANCHORS	Jul 03, 1995	Substantially Equivalent for Some Indications	BIOMET, INC.
K950704	K4 BONE SCREW SYSTEM	Jun 30, 1995	Substantially Equivalent	KINETIKOS MEDICAL, INC.
K951303	SFC	Jun 27, 1995	Substantially Equivalent	MEDPAC
K950652	OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS	Jun 22, 1995	Substantially Equivalent for Some Indications	OSTEOTECH, INC.
K945687	ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW	Jun 22, 1995	Substantially Equivalent for Some Indications	SMITH AND NEPHEW DONJOY, INC.
K951304	SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER	Jun 16, 1995	Substantially Equivalent for Some Indications	SYNTHES (USA)
K934590	IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS	Jun 14, 1995	Substantially Equivalent	SMITH & NEPHEW RICHARDS, INC.
K950250	MED-SURG SUTURE WASHER	May 17, 1995	Substantially Equivalent for Some Indications	MEDICAL SURGICAL, INC.
K934321	LINVATEC STASYS-PES FIXATION DEVICE	May 10, 1995	Substantially Equivalent	LINVATEC CORP.
K944330	ACUTRAK PLUS FIXATION SYSTEM	May 05, 1995	Substantially Equivalent for Some Indications	ACUMED, INC.
K945426	ARTHREX CANCELLOUS SCREW AND WASHER	Apr 14, 1995	Substantially Equivalent for Some Indications	ARTHREX, INC.
K945236	AIMS CANNULATED ACL SCREW (7MM DIAMETER)	Feb 03, 1995	Substantially Equivalent	SMITH AND NEPHEW DONJOY, INC.
K941941	BONE MULCH SCREW	Feb 02, 1995	Substantially Equivalent for Some Indications	BIOMET, INC.
K945182	DYONICS FIXATION SCREWS	Jan 24, 1995	Substantially Equivalent for Some Indications	SMITH & NEPHEW DYONICS, INC.
K944213	6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW	Dec 09, 1994	Substantially Equivalent for Some Indications	HOWMEDICA CORP.
K943804	BONE SCREW	Dec 08, 1994	Substantially Equivalent for Some Indications	COHORT MEDICAL PRODUCTS GROUP, INC.
K942341	CANNULATED CANCELLOUS BONE SCREW	Dec 05, 1994	Substantially Equivalent for Some Indications	ACUMED, INC.
K942340	CORTICAL BONE SCREW	Dec 05, 1994	Substantially Equivalent for Some Indications	ACUMED, INC.
K941866	PIONEER LABORATORIES CABLE SCREW	Nov 28, 1994	Substantially Equivalent	PIONEER SURGICAL TECHNOLOGY
K940690	PIONEER LABORATORIES BONE SCREW	Nov 22, 1994	Substantially Equivalent for Some Indications	PIONEER SURGICAL TECHNOLOGY
K943539	AIMS CANNULATED ACL SCREW	Oct 19, 1994	Substantially Equivalent	SMITH & NEPHEW, INC.
K943474	CANNULATED BONE SCREW	Oct 14, 1994	Substantially Equivalent	COHORT MEDICAL PRODUCTS GROUP, INC.
K934366	MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER	Oct 07, 1994	Substantially Equivalent for Some Indications	MITEK SURGICAL PRODUCTS, INC.
K943160	INTERFERENCE SCREW	Sep 30, 1994	Substantially Equivalent for Some Indications	APPLIED OSTEO SYSTEMS, INC.
K941174	PIONEER LABORATORIES CABLE PIN	Sep 19, 1994	Substantially Equivalent	PIONEER SURGICAL TECHNOLOGY
K931155	STAPLE, FIXATION BONE; SCREW FIXATION BONE	Sep 01, 1994	Substantially Equivalent	ROSEBURG SA
K932721	ARTHROTEK SET SCREW	Aug 01, 1994	Substantially Equivalent for Some Indications	BIOMET, INC.
K940207	TITANIUM ALLOY BONE SCREWS	Jul 12, 1994	Substantially Equivalent	AESCULAP, INC.
K933719	BIOSCREW ABSORBABLE INTERFERENCE SCREW	May 17, 1994	Substantially Equivalent for Some Indications	LINVATEC CORP.
K931680	CANNULATED CANCELLOUS SCREW	May 04, 1994	Substantially Equivalent for Some Indications	ONYX MEDICAL CORP.
K931538	AMSET(TM) CANNULATED BONE SCREW	May 04, 1994	Substantially Equivalent for Some Indications	ADVANCED MED/SURG, INC.
K931652	ACE 6.5 MM BONE SCREW	Apr 28, 1994	Substantially Equivalent for Some Indications	ACE MEDICAL CO.
K934616	CANCELLOUS BONE SCREW	Apr 25, 1994	Substantially Equivalent for Some Indications	ONYX MEDICAL CORP.
K934615	CANCELLOUS BONE SCREW	Apr 25, 1994	Substantially Equivalent for Some Indications	ONYX MEDICAL CORP.
K931790	CORTICAL BONE SCREW	Apr 25, 1994	Substantially Equivalent for Some Indications	ONYX MEDICAL CORP.
K931681	CANNULATED NAVICULAR SCREW	Apr 25, 1994	Substantially Equivalent for Some Indications	ONYX MEDICAL CORP.
K935836	BONE OR INTERFERENCE SCREW	Apr 15, 1994	Substantially Equivalent for Some Indications	ENDO SURGICAL CONCEPTS, INC.
K934044	ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM	Mar 10, 1994	Substantially Equivalent	SMITH AND NEPHEW DONJOY, INC.
K932862	ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW	Mar 10, 1994	Substantially Equivalent for Some Indications	SMITH AND NEPHEW DONJOY, INC.
K931524	FULLY THREADED ALTA CANCELLOUS BONE SCREW	Mar 01, 1994	Substantially Equivalent	HOWMEDICA CORP.
K934469	ARTHROTEK INTERFERENCE SCREW	Feb 23, 1994	Substantially Equivalent for Some Indications	BIOMET, INC.
K933738	M. KUROSAKA INTERFERENCE FIXATION SCREW	Feb 23, 1994	Substantially Equivalent for Some Indications	DEPUY, INC.
K933352	CONCEPT CANNULATED INTEREFERENCE SCREW	Feb 23, 1994	Substantially Equivalent for Some Indications	LINVATEC CORP.
K932027	OREGON FIXATION SYSTEM INTERFERENCE SCREW	Feb 23, 1994	Substantially Equivalent for Some Indications	ACUMED, INC.
K930107	AME UNIVERSAL BONE SCREW	Feb 22, 1994	Substantially Equivalent	AMERICAN MEDICAL ELECTRONICS, INC.
K931665	6.5 MM CANCELLOUS BONE SCREW	Feb 17, 1994	Substantially Equivalent	ENCORE ORTHOPEDICS, INC.
K930980	INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW	Feb 10, 1994	Substantially Equivalent for Some Indications	INSTRUMENT MAKAR, INC.
K931187	IMPLEX ACETABULAR CUP SCREW SYSTEM	Feb 07, 1994	Substantially Equivalent	IMPLEX CORP.
K930970	BAUMER SCREWS	Jan 07, 1994	Substantially Equivalent	BAUMER ORTOPEDIA LTD.
K925328	ANSPACH BONE RIVET, ANSPACH SUTURE ANCHOR	Oct 27, 1993	Substantially Equivalent	ANSPACH MFG., INC.
K923841	BONE SCREWS	Oct 27, 1993	Substantially Equivalent	INSTRUMENT MAKAR, INC.
K921481	INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR	Aug 24, 1993	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K930834	ACUTRACT	Jul 26, 1993	Substantially Equivalent	ACUMED, INC.
K926579	TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE	Apr 06, 1993	Substantially Equivalent	TECHMEDICA, INC.
K924018	M3 LAG SCREW FIXATION SYSTEM	Apr 01, 1993	Substantially Equivalent	OSTEOMED CORP.
K926047	ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW	Mar 31, 1993	Substantially Equivalent	ACE ORTHOPEDIC MANUFACTURING CO.
K923477	3.5MM UNIVERSAL COMPRESSION SCREW	Mar 19, 1993	Substantially Equivalent	HOWMEDICA CORP.
K922788	BIOACTION LOW PROFILE SCREW SYSTEM	Mar 12, 1993	Substantially Equivalent	ORTHOPAEDIC BIOSYSTEMS
K915424	ARTHREX CANNULATED INTERFERENCE SCREW	Feb 09, 1993	Substantially Equivalent	ARTHREX, INC.
K924514	ACUFEX FIXATION POST	Oct 13, 1992	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K923256	ALPHATEC 2.7 MM CANNULATED CORTICAL LAG SCREW	Oct 09, 1992	Substantially Equivalent	ALPHATEC MFG., INC.
K922166	ALPHATEC SMALL FRAGMENT SET	Aug 06, 1992	Substantially Equivalent	ALPHATEC MFG., INC.
K922322	ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW	Aug 05, 1992	Substantially Equivalent	ALPHATEC MFG., INC.
K912640	CONCEPT ENDOSTEAL FIXATION DEVICE	May 01, 1992	Substantially Equivalent	CONCEPT, INC.
K915448	CORTICAL BONE SCREW	Feb 28, 1992	Substantially Equivalent	DOW CORNING WRIGHT
K915316	AAP BONE SCREW	Feb 14, 1992	Substantially Equivalent	AAP INTERNATIONAL, LTD.
K915613	BONE SCREW 3.5 MM	Feb 13, 1992	Substantially Equivalent for Some Indications	ACUMED, INC.
K915124	UNIVERSAL COMPRESION SCREW	Feb 11, 1992	Substantially Equivalent	HOWMEDICA CORP.
K913210	M. KUROSAKA(TM) FIXATION SCREW	Jan 24, 1992	Substantially Equivalent	DEPUY, INC.
K910976	OREGON FIXATION SCREW	Jan 13, 1992	Substantially Equivalent	ACUMED, INC.
K915187	CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW	Dec 19, 1991	Substantially Equivalent	TECHMEDICA, INC.
K914004	ALPHATEC CANNULATED BONE SCREWS	Dec 05, 1991	Substantially Equivalent	ALPHATEC MFG., INC.
K912598	ACE CORTICAL BONE SCREW	Nov 27, 1991	Substantially Equivalent for Some Indications	ACE MEDICAL CO.
K913269	OSTEO BONE SCREWS	Nov 22, 1991	Substantially Equivalent	FRED C. BRYSON
K912021	MAKAR MINI CANNULATED CANCELLOUS SCREWS	Nov 22, 1991	Substantially Equivalent	INSTRUMENT MAKAR, INC.
K913415	AESCULAP TITANIUM BONE SCREWS	Oct 29, 1991	Substantially Equivalent for Some Indications	AESCULAP, INC.
K911768	AMSET(TM) BONE SCREW	Oct 04, 1991	Substantially Equivalent	ADVANCED MED/SURG, INC.
K910193	HUENE FIXATION SCREW	Aug 23, 1991	Substantially Equivalent for Some Indications	ACU-MED, INC.
K904809	UNIVERSAL COMPRESSION SCREW	Jun 28, 1991	Substantially Equivalent for Some Indications	HOWMEDICA CORP.
K911398	ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM	Jun 27, 1991	Substantially Equivalent for Some Indications	HOWMEDICA CORP.
K905048	ACE 3.5MM CORTICAL BONE SCREW	Jan 30, 1991	Substantially Equivalent	ACE MEDICAL CO.
K905358	CANCELLOUS SCREW	Jan 04, 1991	Substantially Equivalent for Some Indications	O'TEC CORP.
K905357	CORTICAL BONE SCREW (EUROPEAN STYLE)	Jan 04, 1991	Substantially Equivalent for Some Indications	O'TEC CORP.
K905333	U.S. TYPE CRUCIATE SLOT BONE SCREW	Jan 04, 1991	Substantially Equivalent for Some Indications	O'TEC CORP.
K903811	ACE CANNULATED CORTICAL BONE SCREW	Oct 16, 1990	Substantially Equivalent for Some Indications	ACE MEDICAL CO.
K903810	ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW	Oct 16, 1990	Substantially Equivalent for Some Indications	ACE MEDICAL CO.
K901144	LEVTECH BONE SCREW	Oct 10, 1990	Substantially Equivalent	LEVTECH, INC.
K901814	MCGRATH ORTHOPAEDIC BONE SCREWS	Aug 21, 1990	Substantially Equivalent for Some Indications	MCGRATH SURGICAL LTD.
K903259	KNOWLES PIN	Aug 09, 1990	Substantially Equivalent for Some Indications	ONYX MEDICAL CORP.
K903258	HAGIE PIN	Aug 09, 1990	Substantially Equivalent for Some Indications	ONYX MEDICAL CORP.
K903255	CORTICAL BONE SCREW (EUROPEAN STYLE)	Aug 09, 1990	Substantially Equivalent for Some Indications	ONYX MEDICAL CORP.
K903254	U.S. TYPE CRUCIATE SLOT BONE SCREW	Aug 09, 1990	Substantially Equivalent for Some Indications	ONYX MEDICAL CORP.
K903253	CANCELLOUS SCREW	Aug 09, 1990	Substantially Equivalent for Some Indications	ONYX MEDICAL CORP.
K903244	LAG SCREW	Jul 30, 1990	Substantially Equivalent	ONYX MEDICAL CORP.
K901616	CANNULATED INTERFERENCE SCREW SYSTEM	Jun 20, 1990	Substantially Equivalent	SMITH & NEPHEW DYONICS, INC.
K900132	ACUFEX STERILE CANNULATED INTERFERENCE SCREW;	Mar 28, 1990	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K895711	ACUFEX INTERFERENCE SCREW, STERILE	Jan 09, 1990	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K896601	EXACTECH BONE SCREW	Dec 06, 1989	Substantially Equivalent	EXACTECH, INC.
K895389	DEPUY (TM) TRUE COMPRESSION SCREW	Nov 24, 1989	Substantially Equivalent	DEPUY, INC.
K896044	CROSS CANCELLOUS BONE SCREW	Nov 09, 1989	Substantially Equivalent for Some Indications	BUCKMAN CO., INC.
K895766	ASNIS II GUIDED BONE SCREW	Nov 08, 1989	Substantially Equivalent	HOWMEDICA CORP.
K894719	CYPRESS MEDICAL BONE SCREW & PLATES	Oct 20, 1989	Substantially Equivalent	CYPRESS MEDICAL MFG., INC.
K895219	CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM	Sep 12, 1989	Substantially Equivalent	ORTHOPEDIC SYSTEMS, INC.
K895218	CANCELLOUS SCREW SHORT THREAD DIAMETER 6.5MM	Sep 12, 1989	Substantially Equivalent	ORTHOPEDIC SYSTEMS, INC.
K895217	CORTICAL SCREW	Sep 12, 1989	Substantially Equivalent	ORTHOPEDIC SYSTEMS, INC.
K894124	OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS	Sep 11, 1989	Substantially Equivalent for Some Indications	OSTEONICS CORP.
K894830	CYPRESS CANNULATED BONE SCREW	Aug 30, 1989	Substantially Equivalent	CYPRESS MEDICAL MFG., INC.
K893512	DEPUY CANNULATED BONE SCREW	Aug 21, 1989	Substantially Equivalent	DEPUY, INC.
K892925	VECSEI EXPANDING SCREW	Aug 07, 1989	Substantially Equivalent	HOWMEDICA CORP.
K892214	REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW	Jun 22, 1989	Substantially Equivalent	ACE MEDICAL CO.
K882934	CASF CANCELLOUS BONE SCREW, BT650	Oct 13, 1988	Substantially Equivalent	TERRAY MANUFACTURING, INC.
K883910	ACUFEX INTERFERENCE SCREW AND SCREWDRIVER	Oct 12, 1988	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K882831	ACE CANCELLOUS BONE SCREW	Aug 01, 1988	Substantially Equivalent	BUCKMAN CO., INC.
K881327	STUART CANNULATED CANCELLOUS BONE FIXATION SCREW	May 25, 1988	Substantially Equivalent	STUART DRUG & SURGICAL SUPPLY, INC.
K874676	INTERFERENCE SCREW	Mar 07, 1988	Substantially Equivalent	CONCEPT, INC.
K875053	ACROMED CANCELLOUS BONE SCREW	Jan 20, 1988	Substantially Equivalent	BUCKMAN CO., INC.
K875050	ORTHOMET BONE SCREWS	Jan 07, 1988	Substantially Equivalent	ORTHOMET, INC.
K874670	ACE CANNULATED SELF-TAPPING CORTICAL BONE SCREW	Dec 17, 1987	Substantially Equivalent	BUCKMAN CO., INC.
K874672	ACE CORTICAL LAG SCREW	Dec 11, 1987	Substantially Equivalent	BUCKMAN CO., INC.
K874130	TITANIUM BONE SCREWS	Dec 07, 1987	Substantially Equivalent	ORTHOPEDIC SYSTEMS, INC.
K874593	ACE SELFTAPPING CANCELLOUS BONE SCREW	Nov 24, 1987	Substantially Equivalent	ACE MEDICAL CO.
K873251	OMNIFIT BONE SCREW	Sep 18, 1987	Substantially Equivalent for Some Indications	OSTEONICS CORP.
K872859	ACE CANCELLOUS BONE SCREW	Aug 17, 1987	Substantially Equivalent	ACE MEDICAL CO.
K872738	CORTICAL BONE SCREWS	Jul 30, 1987	Substantially Equivalent	MILITARY ENGINEERING, INC.
K872156	CONCEPT SELF COMPRESSING CANNULATED SCREW SYSTEM	Jul 21, 1987	Substantially Equivalent	CONCEPT, INC.
K871037	CANCELLOUS FIXATION SCREW & WASHER FOR USE W/SCREW	Mar 25, 1987	Substantially Equivalent	CONCEPT, INC.
K870141	URESIL T-SYSTEM BONE SCREWS	Feb 03, 1987	Substantially Equivalent	URESIL CORP.
K864633	VITALLIUM HEX-DRIVE BONE SCREW SYSTEM	Dec 18, 1986	Substantially Equivalent	HOWMEDICA CORP.
K864626	CANCELLOUS BONE SCREW	Dec 15, 1986	Substantially Equivalent	DOW CORNING WRIGHT
K862230	WARSAW ORTHOPEDIC CANCELLOUS BONE SCREW	Aug 29, 1986	Substantially Equivalent	BUCKMAN CO., INC.
K854336	MONOFIXATEUR	Mar 05, 1986	Substantially Equivalent	ORTOPEDIA GMBH
K860323	REESE ARTHRODESIS SCREW	Feb 19, 1986	Substantially Equivalent	OSTEOTOMY GUIDE CO.
K860017	ACROMED CANCELLOUS BONE SCREW	Feb 07, 1986	Substantially Equivalent	BUCKMAN CO., INC.
K855031	MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P	Jan 21, 1986	Substantially Equivalent	ADVANCED BIOSEARCH ASSN.
K854827	LINK CORTICAL SCREWS	Dec 27, 1985	Substantially Equivalent	LINK AMERICA, INC.
K854826	LINK CANCELLOUS SCREWS	Dec 27, 1985	Substantially Equivalent	LINK AMERICA, INC.
K853869	TITANIUIM BONE SCREW	Dec 09, 1985	Substantially Equivalent	GEORGE TIEMANN & CO.
K852026	FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER	May 22, 1985	Substantially Equivalent	WARSAW ORTHOPEDIC, INC.
K850024	ORTHOPEDIC IMPLANT SCREWS	May 20, 1985	Substantially Equivalent	KIRKSTIL CORP., INC.
K851214	T-SCREW	Apr 22, 1985	Substantially Equivalent	NORTHEAST IOWA PODIATRY
K850770	INTERMEDICS BONE SCREW	Apr 19, 1985	Substantially Equivalent	INTERMEDICS ORTHOPEDICS
K831873	BONE SCREW	Aug 12, 1983	Substantially Equivalent	W.L. GORE & ASSOCIATES,INC
K810497	BONE FIXACTION SCREW	Mar 11, 1981	Substantially Equivalent	SERRANO INTL.
K810205	MECRON CANCELLOUS CANNULATED BONE SCREWS	Feb 09, 1981	Substantially Equivalent	SERRANO INTL.
K792205	SEIDEL INTRAMEDULLARY PLUG	Dec 06, 1979	Substantially Equivalent	HOWMEDICA CORP.
K792022	HERBERT BONE SCREW	Oct 26, 1979	Substantially Equivalent	ZIMMER, INC.
K780235	ORTHOPEDIC DEVICES	Feb 23, 1978	Substantially Equivalent	BIOMET, INC.
K770035	SCREW, WADSWORTH OLECRANON	Jan 14, 1977	Substantially Equivalent	ORTHOPEDIC EQUIPMENT CO., INC.

FEI Numbers

This FDA classification entry is associated with 653 FEI numbers. Click on an entry to view related FDA registrations.

1000069183: 23 registrations

1000114185: 228 registrations

1000115331: 61 registrations

1000115656: 99 registrations

1000115735: 15 registrations

1000116116: 174 registrations

1000116912: 176 registrations

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1000136478: 184 registrations

1000139987: 90 registrations

1000143502: 90 registrations

1000185904: 31 registrations

1000199976: 114 registrations

1000219637: 355 registrations

1000220336: 8 registrations

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1000221916: 120 registrations

1000272060: 41 registrations

1000306139: 80 registrations

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1000306340: 148 registrations

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1018470: 468 registrations

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1036836: 105 registrations

1038671: 212 registrations

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1051526: 42 registrations

1219602: 159 registrations

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1221051: 23 registrations

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1832656: 81 registrations

1935627: 169 registrations

2011171: 834 registrations

2020550: 546 registrations

2020601: 37 registrations

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2024024: 189 registrations

2027148: 16 registrations

2027754: 95 registrations

2183449: 175 registrations

2183650: 37 registrations

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2242056: 12 registrations

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2647346: 243 registrations

2648045: 124 registrations

2648209: 57 registrations

2648623: 99 registrations

2648666: 61 registrations

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2936485: 235 registrations

3000170817: 118 registrations

3000190635: 31 registrations

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3000215273: 514 registrations

3000215566: 12 registrations

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3000327445: 24 registrations

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3007993775: 108 registrations

3008034554: 3 registrations

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3010303097: 91 registrations

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3010331645: 349 registrations

3010363503: 132 registrations

3010370880: 25 registrations

3010375065: 69 registrations

3010383847: 63 registrations

3010400367: 223 registrations

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3010536692: 283 registrations

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3010707607: 263 registrations

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