Product Code: HSB FDA class 2 21 CFR 888.3020

Rod, Fixation, Intramedullary And Accessories

Orthopedic

An intramedullary rod and accessories system is a set of surgically implanted metallic rods and associated components inserted into the medullary canal of long bones to stabilize and align fractures during healing. It is classified as an FDA Class 2 device under 21 CFR 888.3020, indicating moderate risk and requiring 510(k) premarket clearance. Product code HSB falls under the Orthopedic medical specialty. This device is an implant.

View on FDA

510(k)s

529

FEI Numbers

302

Registration Numbers

302

Unique Applicants

180

Years Active

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Basic Information

Product Code: HSB
Device Class: FDA class 2
Regulation Number: 888.3020
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 529 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K261651	Precice Max System and Precice Ankle Salvage System	Jun 18, 2026	Substantially Equivalent	NuVasive Specialized Orthopedics
K253080	AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)	Jun 18, 2026	Substantially Equivalent	Suzhou and Science & Technology Development Corp.
K253155	Fule Metallic Lockable Intramedullary Nail Systems	Jun 17, 2026	Substantially Equivalent	Beijing Fule Science & Technology Development Co., Ltd.
K253046	HERA Interlocking Intramedullary Nailing System	Jun 16, 2026	Substantially Equivalent	ZheJiang Decans Medical Devices Co., Ltd.
K260146	FITBONE® TRANSPORT AND LENGTHENING SYSTEM	May 19, 2026	Substantially Equivalent	Orthofix Srl
K253991	Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA	May 08, 2026	Substantially Equivalent	Orthofix Srl
K261043	AUTOBAHN Nailing System	Apr 24, 2026	Substantially Equivalent	Globus Medical, Inc.
K252016	Arthrex Humeral Nails	Mar 20, 2026	Substantially Equivalent	Arthrex, Inc.
K252961	Fusion FibFix Nail	Mar 18, 2026	Substantially Equivalent	Fusion Orthopedics USA, LLC
K253566	Affixus Retrograde Femoral Nailing System	Mar 12, 2026	Substantially Equivalent	Zimmer, Inc.
K253517	Reselute Tibial Nail	Mar 10, 2026	Substantially Equivalent	Reselute, Inc.
K253591	Phantom® Hindfoot TTC/TC Nail System	Mar 05, 2026	Substantially Equivalent	Paragon 28, Inc.
K252196	Arthrex FibuLock Nail System	Mar 05, 2026	Substantially Equivalent	Arthrex, Inc.
K252025	Active Intramedullary (AIM) Tibial Nail System	Mar 04, 2026	Substantially Equivalent	Satori Orthopaedics, Inc.
K253640	T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System	Feb 03, 2026	Substantially Equivalent	Stryker GmbH
K253749	Affixus® Natural Nail® Proximal Humeral System	Dec 12, 2025	Substantially Equivalent	Zimmer Switzerland Manufacturing GmbH
K252826	ARIX Femur Nail System	Dec 10, 2025	Substantially Equivalent	Jeil Medical Corporation
K250197	Estremo Fibular Nail	Oct 17, 2025	Substantially Equivalent	Citieffe S.R.L.
K250628	DynaNail TTC Fusion System	Sep 12, 2025	Substantially Equivalent	MedShape, Inc.
K251400	T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System	Aug 20, 2025	Substantially Equivalent	Stryker GmbH
K250163	T2 Alpha Femur Retrograde Nailing System	Aug 13, 2025	Substantially Equivalent	Stryker GmbH
K250622	Succession AFN System	Aug 07, 2025	Substantially Equivalent	Ortho Solutions UK , Ltd.
K251850	Phantom® Hindfoot TTC/TC Nail System	Jul 14, 2025	Substantially Equivalent	Paragon 28, Inc.
K250559	GMReis Fibula Nail System	Jun 12, 2025	Substantially Equivalent	Gm Dos Reis Industria E Comercio
K242247	ARIX Femur Nail System	Apr 22, 2025	Substantially Equivalent	Jeil Medical Corporation
K250112	FitboneTM Trochanteric	Apr 10, 2025	Substantially Equivalent	Orthofix Srl
K250623	Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur	Apr 01, 2025	Substantially Equivalent	OrthoPediatrics Corp.
K241983	Fassier-Duval Telescoping IM System	Feb 21, 2025	Substantially Equivalent	Orthopediatrics Canada Ulc Dba Pega Medical
K243907	Affixus Tibial Nailing System - 4mm screws	Feb 12, 2025	Substantially Equivalent	Zimmer, Inc.
K243890	Arthrex Intramedullary Nails	Jan 13, 2025	Substantially Equivalent	Arthrex, Inc.
K243364	TRIGEN META-TAN Trochanteric Antegrade Nail	Dec 09, 2024	Substantially Equivalent	Smith & Nephew, Inc.
K241484	Atlas Humeral Nail System	Nov 05, 2024	Substantially Equivalent	Orthopedic Designs North America, Inc. (Odi-Na)
K241651	Affixus Tibial and Antegrade Femoral Nailing System	Sep 26, 2024	Substantially Equivalent	Zimmer, Inc.
K234128	Phantom Fibula Nail System	Aug 22, 2024	Substantially Equivalent	Paragon 28, Inc.
K230071	Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System	Aug 22, 2024	Substantially Equivalent	Tdm Co., Ltd.
K233696	DePuy Synthes Retrograde Femoral Nail Advanced System	Aug 01, 2024	Substantially Equivalent	DePuy Synthes
K233867	Fitbone Trochanteric	Jun 18, 2024	Substantially Equivalent	Orthofix Srl
K232648	RODEO Telescopic Nail	May 03, 2024	Substantially Equivalent	Orthofix Srl
K233910	Vertex Hip Fracture Nailing System	Apr 04, 2024	Substantially Equivalent	Orthoxel Dac
K232169	FITBONE® Transport and Lengthening System	Mar 22, 2024	Substantially Equivalent	Orthofix Srl
K233134	I.T.S. INS Proximal Femur Nail	Feb 12, 2024	Substantially Equivalent	I.T.S. GmbH
K234075	Flow-Nail	Feb 05, 2024	Substantially Equivalent	Flow-Fx, LLC
K231343	Redemption Duo Hindfoot Nail System	Jan 30, 2024	Substantially Equivalent	Vilex, LLC
K232267	Precice Max System	Dec 15, 2023	Substantially Equivalent	Nuvasive Specialized Orthopedics, Incorporated
K230352	Tornier Humeral Nail and Tornier Long Humeral Nail	Oct 31, 2023	Substantially Equivalent	Tornier, Inc.
K230765	Precice Ankle Salvage System	Aug 29, 2023	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.
K231266	Pediatric Nailing Platform Tibia	Aug 21, 2023	Substantially Equivalent	OrthoPediatrics Corp.
K231114	Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System	Aug 09, 2023	Substantially Equivalent	Zimmer Switzerland Manufacturing GmbH
K230257	Arthrex Intramedullary Nails	Jul 17, 2023	Substantially Equivalent	Arthrex, Inc.
K230456	SGM Femoral Nail System	Jun 30, 2023	Substantially Equivalent	Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
K230512	Gamma4 System	Jun 09, 2023	Substantially Equivalent	Stryker GmbH
K220234	Precice Intramedullary Limb Lengthening System	Mar 15, 2023	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.
K221621	Pro-X1 Trochanteric Nailing System	Mar 06, 2023	Substantially Equivalent	X-Bolt Orthopedics
K221084	Dyna Locking Trochanteric Nail	Mar 03, 2023	Substantially Equivalent	Innosys
K221221	Advanced Intramedullary Nail System	Dec 21, 2022	Substantially Equivalent	Double Medical Technology, Inc.
K221031	Arthrex DualCompression Hindfoot Fusion Nail Implant System	Dec 20, 2022	Substantially Equivalent	Arthrex, Inc.
K221021	Femoral Trochanteric Nail System Neonail	Dec 06, 2022	Substantially Equivalent	Neoortho Produtos Ortopédicos S/A
K222390	Flex-Thread Ulna Intramedullary Nail System	Nov 21, 2022	Substantially Equivalent	Flower Orthopedics Corporation Dba Conventus Flower
K222309	Gamma4 System	Nov 15, 2022	Substantially Equivalent	Stryker GmbH
K210980	Smith & Nephew Intramedullary Nail Systems	Nov 14, 2022	Substantially Equivalent	Smith & Nephew, Inc.
K221489	Artemis Proximal Femoral Nail System	Oct 27, 2022	Substantially Equivalent	Glw, Inc.
K220659	AUTOBAHN(R) EVO Femoral Nails	Sep 09, 2022	Substantially Equivalent	Globus Medical, Inc.
K220679	Pediatric Nailing Platform Femur	Jul 20, 2022	Substantially Equivalent	OrthoPediatrics Corp.
K221115	Flow-Nail	May 13, 2022	Substantially Equivalent	Flow-Fx, LLC
K213328	Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System	Feb 11, 2022	Substantially Equivalent	Stryker GmbH
K203811	GPC Intraheal Intramedullary Nailing System	Feb 10, 2022	Substantially Equivalent	Gpc Medical Limited
K211086	The Progen Trochanteric Nail System	Dec 21, 2021	Substantially Equivalent	Ortho Development Corporation
K212030	Flex-Thread Distal Fibula lntramedullary Nail System	Jul 23, 2021	Substantially Equivalent	Flower Orthopedics Corporation Dba Conventus Flower
K201147	Elos® Intramedullary Nailing System	Jul 19, 2021	Substantially Equivalent	Intrauma S.P.A
K210869	Phantom Hindfoot TTC/TC Nail System	Jun 28, 2021	Substantially Equivalent	Paragon 28, Inc.
K211292	Fassier-Duval Telescopic IM System	May 26, 2021	Substantially Equivalent	Pega Medical, Inc.
K210285	Adaptable Ortho Innovations Intramedullary Nail System	Mar 18, 2021	Substantially Equivalent	Adaptable Ortho Innovations, LLC
K203819	T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System	Feb 26, 2021	Substantially Equivalent	Stryker GmbH
K201379	Artemis Proximal Femoral Nail System	Feb 19, 2021	Substantially Equivalent	Glw, Inc.
K203399	FITBONE(R) TAA	Feb 17, 2021	Substantially Equivalent	Wittenstein Intens GmbH
K202858	Flex-ThreadTM Distal Fibula Intramedullary Nail System	Jan 22, 2021	Substantially Equivalent	Conventus Orthopaedics, LLC
K202348	External Remote Controller ERC 4P	Dec 22, 2020	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.
K202935	Syntec Femoral Nail Extended System	Oct 28, 2020	Substantially Equivalent	Syntec Scientific Corporation
K200127	TELEGRAPH® EVOLUTION Humeral Nailing System	Oct 01, 2020	Substantially Equivalent	FH Industrie
K201346	DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm	Sep 23, 2020	Substantially Equivalent	Synthes (USA) Products, LLC
K200430	Precice® Ankle Salvage System	Sep 16, 2020	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.
K202099	AOS Galileo Trochanteric Nail System	Aug 28, 2020	Substantially Equivalent	Advanced Orthopaedic Solutions, Inc.
K201830	ANSER Clavicle Pin	Aug 27, 2020	Substantially Equivalent	BAAT Medical Products B.V.
K201567	Precice® Bone Transport System	Aug 10, 2020	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.
K200869	Gamma3 System	Jul 22, 2020	Substantially Equivalent	Stryker Trauma GmbH
K201227	Phantom® Hindfoot TTC/TC Nail System	Jul 17, 2020	Substantially Equivalent	Paragon 28, Inc.
K200880	T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System	Jul 01, 2020	Substantially Equivalent	Stryker GmbH
K192710	The Simple Locking Intramedullary (Slim) System	Jun 24, 2020	Substantially Equivalent	Pega Medical, Inc.
K193617	Precice® Screws	May 08, 2020	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.
K193016	PRECICE Bone Transport System	May 08, 2020	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.
K200814	Affixus(R) Natural Nail(R) System Humeral Nail	Apr 28, 2020	Substantially Equivalent	Zimmer GmbH
K193308	T2 Alpha Tibia Nailing System, IMN Screws System	Feb 23, 2020	Substantially Equivalent	Stryker Trauma GmbH
K192163	TTC Phantom® Intramedullary Nail System	Jan 31, 2020	Substantially Equivalent	Paragon 28, Inc.
K183666	EBA One Nailing System	Nov 14, 2019	Substantially Equivalent	Citieffe S.R.L.
K192312	Zimmer Natural Nail System Cephalomedullary Nails	Oct 11, 2019	Substantially Equivalent	Zimmer GmbH
K190321	Pediatric Nailing PlatformFemur	Oct 09, 2019	Substantially Equivalent	OrthoPediatrics Corp.
K191336	PRECICE System	Sep 26, 2019	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.
K191782	TTC Phantom Intramedullary Nail System	Sep 06, 2019	Substantially Equivalent	Paragon 28, Inc.
K191617	Syntec Tibial Nail System	Sep 03, 2019	Substantially Equivalent	Syntec Scientific Corporation
K191598	AOS ES Retrograde Femoral Nail	Jul 18, 2019	Substantially Equivalent	Advanced Orthopaedic Solutions, Inc.
K191238	Zimmer Guide Wire Devices	Jul 05, 2019	Substantially Equivalent	Zimmer, Inc.
K191271	T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System	Jun 11, 2019	Substantially Equivalent	Stryker Trauma GmbH
K181296	Syntec Femoral Nail System	Apr 11, 2019	Substantially Equivalent	Syntec Scientific Corporation
K182170	PRECICE® BONE TRANSPORT System	Feb 05, 2019	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.
K181540	Estremo Citieffe Nailing System	Jan 16, 2019	Substantially Equivalent	Citieffe S.R.L.
K182307	Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System	Jan 14, 2019	Substantially Equivalent	Paragon 28, Inc.
K183162	Affixus Hip Fracture Nail	Dec 14, 2018	Substantially Equivalent	Biomet, Inc.
K181827	Affixus Natural Nail System Humeral Nail	Dec 14, 2018	Substantially Equivalent	Zimmer GmbH
K181639	Panta 2 Arthrodesis Nail System	Nov 02, 2018	Substantially Equivalent	Integra LifeSciences Corporation
K181026	OsteoBridge IDSF System	Oct 17, 2018	Substantially Equivalent	Merete GmbH
K181640	X-BOLT Hip Fracture Fixation System	Oct 12, 2018	Substantially Equivalent	X-Bolt Orthopaedics
K172830	Double Medical Femoral Nail System	Aug 24, 2018	Substantially Equivalent	Double Medical Technology, Inc.
K181184	OIC Intramedullary Nail System	Jul 27, 2018	Substantially Equivalent	The Orthopaedic Implant Company
K173656	Arthrex FibuLock Nail	Jul 26, 2018	Substantially Equivalent	Arthrex, Inc.
K181375	Apex Femoral Nailing System	Jul 17, 2018	Substantially Equivalent	Orthoxel
K180436	T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System	Jun 06, 2018	Substantially Equivalent	Stryker Trauma GmbH
K172583	OrthoPediatrics PediNail Intramedullary Platform	May 10, 2018	Substantially Equivalent	Orthopediatrics, Inc.
K172699	Agile Nail	Apr 23, 2018	Substantially Equivalent	Orthofix Srl
K180503	PRECICE STRYDE System	Apr 03, 2018	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.
K173811	TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System	Mar 15, 2018	Substantially Equivalent	In2bones Sas
K173255	Talon DistalFix Humeral Nail	Feb 22, 2018	Substantially Equivalent	Orthopedic Designs North America, Inc.
K172189	Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt	Jan 16, 2018	Substantially Equivalent	Truemed Group, LLC
K172774	T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System	Jan 12, 2018	Substantially Equivalent	Stryker Trauma GmbH
K171108	AUTOBAHN Nailing System	Dec 29, 2017	Substantially Equivalent	Globus Medical, Inc.
K173652	Piccolo Composite Nailing System	Dec 28, 2017	Substantially Equivalent	CarboFix Orthopedics , Ltd.
K170972	Apex Tibial Nailing System	Dec 20, 2017	Substantially Equivalent	Orthoxel
K173458	ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System	Dec 07, 2017	Substantially Equivalent	Orthofix Srl
K173129	PRECICE System	Dec 01, 2017	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.
K172157	DePuy Synthes Femoral Recon Nail System	Nov 14, 2017	Substantially Equivalent	Synthes (USA) Products, LLC
K171376	DynaNail TTC Fusion System	Nov 02, 2017	Substantially Equivalent	MedShape, Inc.
K172943	Flex-Thread Fibula Pin System	Oct 30, 2017	Substantially Equivalent	Intrafuse, LLC
K163653	NOVOS-NAIL Limb Lengthening System (LLS)	Oct 13, 2017	Substantially Equivalent	Smith & Nephew
K172628	PRECICE System	Sep 25, 2017	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.
K163627	Shotel Ankle Arthrodesis Nail System	Sep 14, 2017	Substantially Equivalent	Biopro, Inc.
K172061	PRECICE UNYTE System	Aug 24, 2017	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.
K172114	Zimmer Natural Nail System	Aug 10, 2017	Substantially Equivalent	Zimmer, Inc.
K163589	SIGN IM Nail	Jul 20, 2017	Substantially Equivalent	Sign Fracture Care International
K170169	PRECICE Intramedullary Limb Lengthening System	Jun 09, 2017	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.
K161327	SYNTEC HUMERAL NAIL SYSTEM	Jun 08, 2017	Substantially Equivalent	Syntec Scientific Corporation
K162927	PRECICE UNYTE CoCr System	Apr 06, 2017	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.
K163488	Flex-Thread Clavicle Pin System	Mar 20, 2017	Substantially Equivalent	Intrafuse, LLC
K170346	PRECICE Intramedullary Limb Lengthening System	Mar 07, 2017	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.
K161371	Sonoma Fifth Metatarsal Repair System	Feb 24, 2017	Substantially Equivalent	Sonoma Orthopedic Products, Inc.
K163368	FITBONE TAA	Jan 26, 2017	Substantially Equivalent	Wittenstein Intens GmbH
K163014	AOS Small Bone Nailing System	Jan 24, 2017	Substantially Equivalent	Advanced Orthopaedic Solutions, Inc. (Aos)
K161466	ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System	Jan 24, 2017	Substantially Equivalent	Orthofix Srl
K161264	TRIGEN Low Profile Bone Screws	Nov 23, 2016	Substantially Equivalent	Smith & Nephew, Inc.
K160545	GAP ENDO-EXO MEDULLARY SYSTEM	Nov 23, 2016	Substantially Equivalent	Pega Medical, Inc.
K161254	Renovo Life Small Bone IM Nail System	Nov 07, 2016	Substantially Equivalent	Renovo Life, LLC
K160167	DePuy Synthes TFNA Augmentation System	Sep 26, 2016	Substantially Equivalent	Synthes (USA) Products, LLC
K160325	PRECICE Intramedullary Limb Lengthening System	Apr 04, 2016	Substantially Equivalent	Ellipse Technologies, Inc.
K160267	PRECICE Trauma Nail System	Mar 31, 2016	Substantially Equivalent	Ellipse Technologies, Incorporated
K160069	Sonoma Fibula Repair System	Mar 10, 2016	Substantially Equivalent	Sonoma Orthopedics Products, Inc.
K153536	Piccolo Composite® Nailing System	Jan 06, 2016	Substantially Equivalent	CarboFix Orthopedics , Ltd.
K152370	PRECICE Trauma Nail System	Dec 22, 2015	Substantially Equivalent	Ellipse Technologies, Incorporated
K151062	WASTON Metallic Intramedullary Nail System	Dec 17, 2015	Substantially Equivalent	Changzhou Waston Medical Appliance Co., Ltd.
K150769	Cardinal Health Trochanteric IM Nail System	Dec 14, 2015	Substantially Equivalent	Cardinalhealth
K152757	SIGN Hip Construct (SHC)	Nov 13, 2015	Substantially Equivalent	Sign Fracture Care International
K152295	Talon DistalFix Antegrade/Retrograde Femoral Nail	Nov 03, 2015	Substantially Equivalent	Orthopedic Designs North America, Inc.
K151456	Small Bone Nail Implant	Oct 29, 2015	Substantially Equivalent	Vilex IN Tennessee, Inc.
K143245	GPC Intramedullary Nailing Systems	Sep 30, 2015	Substantially Equivalent	Gpc Medical Limited
K151010	Piccolo Composite Nailing System	Jul 28, 2015	Substantially Equivalent	CarboFix Orthopedics , Ltd.
K143355	The Simple Locking IntraMedullary (SLIM) System	Jul 10, 2015	Substantially Equivalent	Pega Medical, Inc.
K150655	OIC Intramedullary Nail System	Jul 09, 2015	Substantially Equivalent	Orthopaedic Implant Company
K151131	PRECICE Intramedullary Limb Lengthening System	Jun 19, 2015	Substantially Equivalent	Ellipse Technologies, Incorporated
K150867	Affixus Tibial Nailing System	Jun 10, 2015	Substantially Equivalent	Biomet, Inc.
K143204	AOS Clavicle Intramedullary Device	Jun 03, 2015	Substantially Equivalent	Advanced Orthopaedic Solutions, Inc.
K143321	ITST Intertrochanteric/Subtrochanteric Fixation System	May 29, 2015	Substantially Equivalent	Zimmer, Inc.
K150471	CalcaNail Orthopedic Arthrodesis Nail	May 22, 2015	Substantially Equivalent	Fournitures Hospitalieres Industrie
K150463	CalcaNail Orthopedic Nail	May 22, 2015	Substantially Equivalent	Fournitures Hospitalieres Industrie
K150656	PRECICE Intramedullary Limb Lengthening System	Apr 23, 2015	Substantially Equivalent	Ellipse Technologies, Incorporated
K150073	MICRONAIL Distal Radius System	Feb 10, 2015	Substantially Equivalent	Wrightmedicaltechnologyinc
K142451	OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System	Feb 09, 2015	Substantially Equivalent	Merete Medical GmbH
K143276	Acumed Small Bone IM Nail System	Feb 05, 2015	Substantially Equivalent	Acumed, LLC
K142945	Sonoma Fibula Repair System	Jan 22, 2015	Substantially Equivalent	Sonoma Orthopedic Products, Inc.
K142599	PRECISE Trauma Nail System	Jan 16, 2015	Substantially Equivalent	Ellipse Technologies, Incorporated
K141571	ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM	Nov 12, 2014	Substantially Equivalent	Orthofix Srl
K133166	INS HILDEN TIBIAL ARZZT	Nov 06, 2014	Substantially Equivalent	Truemed Group, LLC
K142602	VALOR Hindfoot Fusion Nail System	Oct 22, 2014	Substantially Equivalent	Wrightmedicaltechnologyinc
K142281	ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM	Oct 22, 2014	Substantially Equivalent	Zimmer, Inc.
K141739	RESIDUAL LIMB LENGTHENING SYSTEM	Oct 07, 2014	Substantially Equivalent	Ellipse Technologies, Inc.
K141347	EMERGE MEDICAL IM NAIL SYSTEM	Oct 02, 2014	Substantially Equivalent	Emerge Medical
K141103	INTRAMEDULLARY NAIL AND SCREWS-NEONAIL	Sep 23, 2014	Substantially Equivalent	Neoortho Produtos Ortopedicos S/A
K141228	AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW	Jul 08, 2014	Substantially Equivalent	Advanced Orthopaedic Solutions, Inc.
K140601	FLOW-NAIL	Jul 02, 2014	Substantially Equivalent	Flow-Fx, LLC
K141447	PRECICE TRAUMA NAIL SYSTEM	Jun 30, 2014	Substantially Equivalent	Ellipse Technologies, Inc.
K131609	DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM	May 21, 2014	Substantially Equivalent	Xiamen Double Engine Medical Material Co., Ltd.
K141023	PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM	May 20, 2014	Substantially Equivalent	Ellipse Technologies, Inc.
K131984	SYNTHES SYNSONIC ULNA NAIL	Mar 31, 2014	Substantially Equivalent	Synthes (Usa)
K132078	METALLIC INTRAMEDULLARY NAIL SYSTEM	Mar 19, 2014	Substantially Equivalent	Tianjin Walkman Biomaterial Co., Ltd.
K133104	VAN HIP FRACTURE SYSTEM	Mar 10, 2014	Substantially Equivalent	Epix Orthopaedic, Corp.
K132945	CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL	Mar 07, 2014	Substantially Equivalent	I.T.S. GmbH
K131548	SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM	Feb 28, 2014	Substantially Equivalent	Synthes (USA) Products, LLC
K131490	ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM	Jan 23, 2014	Substantially Equivalent	Ellipse Technologies, Inc.
K132830	DISTALOCK TIBIAL IM NAIL SYSTEM	Jan 06, 2014	Substantially Equivalent	Dgimed Ortho, Inc.
K133081	TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N	Dec 31, 2013	Substantially Equivalent	Advanced Orthopaedic Solutions, Inc.
K132428	IDEAL	Dec 20, 2013	Substantially Equivalent	Jiangsu Ideal Medical Science & Technology Co., LT
K133289	PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM	Dec 09, 2013	Substantially Equivalent	Ellipse Technologies, Inc.
K133376	AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT	Dec 05, 2013	Substantially Equivalent	Tornier, Inc.
K131677	PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM	Oct 11, 2013	Substantially Equivalent	Ellipse Technologies, Inc.
K131365	T2 TIBIAL NAILING SYSTEM	Oct 10, 2013	Substantially Equivalent	Stryker Trauma AG
K132774	PICCOLO COMPOSITE NAILING SYSTEM	Oct 03, 2013	Substantially Equivalent	CarboFix Orthopedics , Ltd.
K130595	ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL	Sep 17, 2013	Substantially Equivalent	Zimmer, Inc.
K132005	RETROGRADE FEMORAL NAIL	Sep 10, 2013	Substantially Equivalent	Advanced Orthopaedic Solutions, Inc.
K130051	611 ANKLE FUSION NAIL	Jul 15, 2013	Substantially Equivalent	Tornier S.A.S.
K131005	EBA2 FEMORAL NAILING SYSTEM	Jun 25, 2013	Substantially Equivalent	Citieffe S.R.L.
K123810	PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM	Jun 14, 2013	Substantially Equivalent	CarboFix Orthopedics , Ltd.
K123569	ANTEGRADE FEMORAL NAIL	May 24, 2013	Substantially Equivalent	Advanced Orthopaedic Solutions, Inc.
K130147	ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)	May 03, 2013	Substantially Equivalent	Small Bone Innovations, Inc.
K122823	SIGN PEDIATRIC FIN NAIL	Apr 16, 2013	Substantially Equivalent	Sign Fracture Care International
K130625	12MM AND 13MM TIBIAL NAILS	Mar 28, 2013	Substantially Equivalent	Advanced Orthopaedic Solutions, Inc.
K123745	SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL	Mar 25, 2013	Substantially Equivalent	Biomecanica Industria E Comerico DE Productos Orto
K123401	GAMMA3 AND T2 RECON TARGETING DEVICES	Jan 23, 2013	Substantially Equivalent	Stryker Trauma AG
K121312	INTRAMEDULLARY NAIL SYSTEM	Oct 24, 2012	Substantially Equivalent	Weigao Orthopaedic Device Co., Ltd.
K122170	SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION	Oct 19, 2012	Substantially Equivalent	Smith & Nephew, Inc.
K113219	ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM	Oct 19, 2012	Substantially Equivalent	Ellipse Technologies, Inc.
K120148	AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW	Oct 02, 2012	Substantially Equivalent	Advanced Orthopaedic Solutions, Inc.
K121575	OXFORD ANKLE FUSION NAIL(AFN) SYSTEM	Sep 14, 2012	Substantially Equivalent	Ortho Solutions Limited
K120715	ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT	Aug 10, 2012	Substantially Equivalent	Zimmer GmbH
K120807	SYNTHES MULTILOC HUMERAL NAILING SYSTEM	Jul 06, 2012	Substantially Equivalent	Synthes USA Products, LLC
K120419	DYNA LOCKING ANKLE NAIL	May 21, 2012	Substantially Equivalent	U&I Corp.
K102577	FORCE MEDICAL IM NAIL SYSTEM	May 03, 2012	Substantially Equivalent	Force Medical, Inc.
K120978	OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR	May 02, 2012	Substantially Equivalent	Merete Medical GmbH
K112982	ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )	Apr 02, 2012	Substantially Equivalent	Small Bone Innovations, Inc.
K113695	ELLIPSE PRECICE TRAUMA NAIL SYSTEM	Mar 28, 2012	Substantially Equivalent	Ellipse Technologies, Inc.
K113387	CITIEFFE TITANIUM NAILING SYSTEM	Mar 15, 2012	Substantially Equivalent	Citieffe
K113828	DYNANAIL ANKLE ARTHRODESIS NAIL	Feb 29, 2012	Substantially Equivalent	MedShape, Inc.
K113409	S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL	Feb 15, 2012	Substantially Equivalent	Howmedica Osteonics Corp.
K120083	SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)	Feb 08, 2012	Substantially Equivalent	Synthes USA
K111232	GAP ENDO-EXO MEDULLARY SYSTEM	Jan 26, 2012	Substantially Equivalent	Pega Medical, Inc.
K113303	OSLEOBRIDGE IDSF SPACER CONECTOR	Dec 09, 2011	Substantially Equivalent	Merete Medical GmbH
K111891	SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS	Nov 28, 2011	Substantially Equivalent	Synthes (USA) Products, LLC
K102413	FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL	Nov 14, 2011	Substantially Equivalent	Vilex, Inc.
K111352	TALON DISTALFIX PROXIMAL FEMORAL NAIL	Aug 22, 2011	Substantially Equivalent	Orthopedic Designs North America, Inc.
K111550	SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM)	Aug 19, 2011	Substantially Equivalent	Sonoma Orthopedic Products, Inc.
K112059	T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP	Aug 08, 2011	Substantially Equivalent	Stryker
K101934	DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000	Aug 03, 2011	Substantially Equivalent	Medshape Solutions
K101997	ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM	Jul 12, 2011	Substantially Equivalent	Ellipse Technologies, Inc.
K111025	TRIGEN LOW PROFILE BONE SCREW	Jul 01, 2011	Substantially Equivalent	Smith & Nephew, Inc.
K111444	UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION	Jun 22, 2011	Substantially Equivalent	DePuy Orthopaedics, Inc.
K111056	PICCOLO COMPOSITE NAILING SYSTEM	May 03, 2011	Substantially Equivalent	CarboFix Orthopedics , Ltd.
K110552	VALOR(R) ANKLE FUSION NAIL SYSTEM SCREW	Mar 23, 2011	Substantially Equivalent	Wrightmedicaltechnologyinc
K110322	OLECRA INTRAMEDULLARY FIXATION SYSTEM	Mar 04, 2011	Substantially Equivalent	Mylad Orthopedic Solutions
K103002	SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM	Mar 02, 2011	Substantially Equivalent	Synthes (Usa)
K102369	PICCOLO COMPOSITE NAILING SYSTEM	Jan 31, 2011	Substantially Equivalent	N.M.B. Medical Applications, Ltd.
K103533	ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM	Jan 19, 2011	Substantially Equivalent	Advanced Orthopaedic Solutions, Inc.
K102992	T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES	Dec 22, 2010	Substantially Equivalent	Howmedica Osteonics Corp.
K101939	OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM	Oct 07, 2010	Substantially Equivalent	Merete Medical GmbH
K101622	ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS	Oct 01, 2010	Substantially Equivalent	Zimmer, Inc.
K100112	SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)	Sep 28, 2010	Substantially Equivalent	Sonoma Orthopedic Products, Inc.
K100925	ASCENSION ANKLE FUSION NAIL SYSTEM	Jul 12, 2010	Substantially Equivalent	Ascension Orthopedics, Inc.
K092720	WRIST ARTHRODESIS NAIL SYSTEM	Jun 29, 2010	Substantially Equivalent	Skeletal Dynamics, LLC
K093707	DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820	Jun 23, 2010	Substantially Equivalent	U&I Corp.
K100497	QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)	Jun 21, 2010	Substantially Equivalent	N.M.B. Medical Applications, Ltd.
K101438	T2 GREATER TROCHANTER NAIL	Jun 17, 2010	Substantially Equivalent	Howmedica Osteonics Corp.
K100238	HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM	May 11, 2010	Substantially Equivalent	DePuy Orthopaedics, Inc.
K092748	SURESHOT TAN NAILS AND ACCESSORIES	Apr 26, 2010	Substantially Equivalent	Smith & Nephew, Inc.
K100312	DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM	Apr 20, 2010	Substantially Equivalent	Dgimed Ortho, Inc.
K091425	QUANTUM M COMPOSITE NAILING SYSTEM	Jan 21, 2010	Substantially Equivalent	N.M.B. Medical Applications, Ltd.
K092110	WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)	Jan 20, 2010	Substantially Equivalent	Sonoma Orthopedic Products, Inc.
K092771	DYNA LOCKING IM NAIL	Dec 02, 2009	Substantially Equivalent	U&I Corp.
K093089	MAGNUM NAIL	Nov 13, 2009	Substantially Equivalent	Robert Reid, Inc.
K091309	REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX	Nov 05, 2009	Substantially Equivalent	Dgimed Ortho, Inc.
K091566	ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS	Oct 28, 2009	Substantially Equivalent	Zimmer GmbH
K092646	SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW	Sep 25, 2009	Substantially Equivalent	Synthes (Usa)
K091976	BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL	Aug 17, 2009	Substantially Equivalent	Biomet Trauma
K091788	PANTA NAIL (DIA. 10MM), PANTA NAIL XL	Jul 29, 2009	Substantially Equivalent	Newdeal Sas
K090857	VALOR ANKLE FUSION NAIL SYSTEM	Jul 14, 2009	Substantially Equivalent	Wrightmedicaltechnologyinc
K090596	ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM	Jun 30, 2009	Substantially Equivalent	Zimmer, Inc.
K090241	SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS)	Jun 17, 2009	Substantially Equivalent	Synthes (Usa)
K083648	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	May 14, 2009	Substantially Equivalent	Efratgo, Ltd. HI Tech Bio-Surgical
K090478	AOS PROXIMAL HUMERAL NAIL	Mar 26, 2009	Substantially Equivalent	Advanced Orthopaedic Solutions, Inc.
K083726	PEDINAIL INTRAMEDULLARY NAILING SYSTEM	Mar 11, 2009	Substantially Equivalent	OrthoPediatrics Corp.
K083497	ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS	Feb 19, 2009	Substantially Equivalent	Zimmer, Inc.
K083458	INTRAMEDULLARY FIXATION ROD (IFS)	Feb 09, 2009	Substantially Equivalent	Novalign Orthopaedics, Inc.
K090091	OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM	Feb 01, 2009	Substantially Equivalent	Mylad Orthopedic Solutions, LLC
K082754	AEQUALIS HUMERAL NAIL SYSTEM	Jan 27, 2009	Substantially Equivalent	Tornier
K081230	TRAUSON INTRAMEDULLARY NAIL	Jan 13, 2009	Substantially Equivalent	Trauson (Jiangsu) Medical Instrument Co., Ltd.
K083437	MODIFICATION TO T2 RECON NAIL SYSTEM	Dec 18, 2008	Substantially Equivalent	Howmedica Osteonics Corp.
K082770	ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL	Dec 11, 2008	Substantially Equivalent	Zimmer, Inc.
K082018	T2 FLEXIBLE NAIL	Oct 10, 2008	Substantially Equivalent	Howmedica Osteonics Corp.
K081832	ENSPLINTCMX CLAVICLE PIN	Oct 10, 2008	Substantially Equivalent	Sonoma Orthopedic Products, Inc.
K082148	SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION	Aug 11, 2008	Substantially Equivalent	Synthes (Usa)
K081452	SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM	Jul 18, 2008	Substantially Equivalent	Synthes (Usa)
K081356	OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM	Jul 09, 2008	Substantially Equivalent	Mylad Orthopedic Solutions, LLC
K081243	BIOMET PHOENIX ANKLE NAIL SYSTEM	Jun 27, 2008	Substantially Equivalent	Biomet Trauma
K081152	T2 FEMORAL NAIL	Jun 10, 2008	Substantially Equivalent	Howmedica Osteonics Corp.
K073402	SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM	Feb 29, 2008	Substantially Equivalent	Synthes (Usa)
K070761	SANATMETAL NAILS AND PINS	Feb 07, 2008	Substantially Equivalent	Sanatmetal Mfr. of Orthopaedic/Traumatologic Prod.
K071679	METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS	Dec 17, 2007	Substantially Equivalent	Disc-O-Tech Medical Technologies, Ltd.
K070955	ACID ETCHED LAG SCREWS	Oct 12, 2007	Substantially Equivalent	Biomet Orthopedics, Inc.
K072161	BIOMET FEMORAL LOCKING NAIL SYSTEM	Sep 20, 2007	Substantially Equivalent	Biomet Manufacturing Corp
K071944	ACUMED SMALL BONE LOCKING SYSTEM II	Aug 09, 2007	Substantially Equivalent	Acumed, LLC
K070444	AOS TIBIAL NAIL	Jun 14, 2007	Substantially Equivalent	Advanced Orthopaedic Solutions, Inc.
K070843	SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM	May 02, 2007	Substantially Equivalent	Synthes (Usa)
K070294	SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES	Mar 01, 2007	Substantially Equivalent	Synthes (Usa)
K063570	BIOMET TIBIAL LOCKING NAIL SYSTEM	Feb 27, 2007	Substantially Equivalent	Biomet Manufacturing Corp
K063225	METAIZEAU NAILING SYSTEM	Dec 27, 2006	Substantially Equivalent	Howmedica Osteonics Corp.
K061910	SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS)	Sep 21, 2006	Substantially Equivalent	Synthes (Usa)
K051965	OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEM	Jun 16, 2006	Substantially Equivalent	Merete Medical GmbH
K060921	S2 RECON NAIL SYSTEM	Apr 13, 2006	Substantially Equivalent	Howmedica Osteonics Corp.
K053261	ORTHOFIX TITANIUM NAILING SYSTEMS	Dec 12, 2005	Substantially Equivalent	Orthofix Srl
K053105	SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP	Dec 02, 2005	Substantially Equivalent	Synthes (Usa)
K051678	SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM	Sep 21, 2005	Substantially Equivalent	Synthes (Usa)
K052058	MODIFICATION TO: TITANIUM TELEGRAPH HUMERAL NAIL	Aug 22, 2005	Substantially Equivalent	Fournitures Hospitalieres Industrie
K051590	T2 ANKLE ARTHRODESIS NAIL	Jul 29, 2005	Substantially Equivalent	Howmedica Osteonics Corp.
K051624	T2 RECON NAIL SYSTEM	Jul 07, 2005	Substantially Equivalent	Howmedica Osteonics Corp.
K050882	NEWDEAL ANKLE NAIL	May 27, 2005	Substantially Equivalent	New Deal, S.A.
K050241	AOS HUMERAL NAIL	Mar 14, 2005	Substantially Equivalent	Advanced Orthopaedic Solutions, Inc.
K050118	EBI TROCHANTERIC NAIL SYSTEM	Feb 16, 2005	Substantially Equivalent	Ebi, L.P.
K043431	GAMMA3 NAIL SYSTEM	Feb 16, 2005	Substantially Equivalent	Howmedica Osteonics Corp.
K043200	SIGN FIN NAIL	Feb 03, 2005	Substantially Equivalent	Surgical Implant Generation Network (Sign)
K043233	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	Feb 01, 2005	Substantially Equivalent	Efratgo, Ltd. HI Tech Bio-Surgical
K043270	SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES	Jan 31, 2005	Substantially Equivalent	Zimmer GmbH
K043404	MODIFICATION TO T2 PROXIMAL HUMERAL NAIL	Dec 27, 2004	Substantially Equivalent	Howmedica Osteonics Corp.
K042409	MODULAR ARTHRODESIS NAIL	Dec 02, 2004	Substantially Equivalent	Biomet, Inc.
K043052	TRIGEN HINDFOOT FUSION NAIL	Nov 24, 2004	Substantially Equivalent	Smith & Nephew, Inc.
K042396	T2 PROXIMAL HUMERAL NAIL	Oct 08, 2004	Substantially Equivalent	Howmedica Osteonics Corp.
K042440	ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM	Oct 07, 2004	Substantially Equivalent	Alphatec/Nexmed
K042332	TITANIUM TELEGRAPH HUMERAL NAIL	Oct 07, 2004	Substantially Equivalent	Fournitures Hospitalieres Industrie
K042135	SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION)	Oct 07, 2004	Substantially Equivalent	Synthes (Usa)
K042325	TROCHANTERIC NAIL SYSTEM	Sep 08, 2004	Substantially Equivalent	DePuy Orthopaedics, Inc.
K041393	FASSIER-DUVAL TELSCOPIC IM SYSTEM	Aug 17, 2004	Substantially Equivalent	Pega Medical, Inc.
K040929	TRIGEN ADOLESCENT TAN	May 25, 2004	Substantially Equivalent	Smith & Nephew, Inc.
K040336	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	Apr 12, 2004	Substantially Equivalent	Synthes (Usa)
K040462	TRIGEN TROCHANTERIC ANTEGRADE NAIL	Mar 23, 2004	Substantially Equivalent	Smith & Nephew, Inc.
K033878	ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM	Feb 20, 2004	Substantially Equivalent	Depuy Ace
K033806	ACE PROXIMAL HUMERAL NAIL SYSTEM	Feb 20, 2004	Substantially Equivalent	Depuy Ace
K033618	SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM	Feb 05, 2004	Substantially Equivalent	Synthes (Usa)
K034002	GAMMA3 NAIL SYSTEM	Jan 15, 2004	Substantially Equivalent	Howmedica Osteonics Corp.
K033286	ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM	Jan 12, 2004	Substantially Equivalent	Orthopedic Designs, Inc. (Odi)
K033510	MODIFICATION TO TELEGRAPH HUMERAL NAIL	Dec 03, 2003	Substantially Equivalent	Fournitures Hospitalieres Industrie
K033329	DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS	Nov 14, 2003	Substantially Equivalent	Depuy, Inc.
K032523	T2 NAILING SYSTEM	Oct 22, 2003	Substantially Equivalent	Howmedica Osteonics Corp.
K032898	T2 RECON NAIL SYSTEM	Oct 09, 2003	Substantially Equivalent	Howmedica Osteonics Corp.
K032722	TRIGEN STRAIGHT HUMERAL NAIL SYSTEM	Oct 01, 2003	Substantially Equivalent	Smith & Nephew, Inc.
K032588	MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)	Sep 12, 2003	Substantially Equivalent	Disco-O-Tech Medical Technologies, Ltd.
K032548	IP-XS COMPRESSION NAIL SYSTEM	Sep 10, 2003	Substantially Equivalent	Plus Orthopedics
K032579	S2 NAIL SYSTEM	Aug 29, 2003	Substantially Equivalent	Howmedica Osteonics Corp.
K032367	ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL	Aug 12, 2003	Substantially Equivalent	Zimmer, Inc.
K032244	GAMMA 3 NAIL SYSTEM	Aug 08, 2003	Substantially Equivalent	Howmedica Osteonics Corp.
K032097	DEPUY ACE VERSANAIL TIBIAL NAIL	Aug 08, 2003	Substantially Equivalent	DePuy Orthopaedics, Inc.
K031438	ACUMED SMALL BONE LOCKING ROD SYSTEM II	Jul 17, 2003	Substantially Equivalent	Acumed, LLC
K031219	MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)	May 28, 2003	Substantially Equivalent	Orthofix, Inc.
K020885	FASSIRE-DUVAL TELESCOPIC IM SYSTEM	Feb 06, 2003	Substantially Equivalent	Pega Medical, Inc.
K023241	TELEGRAPH HUMERAL NAIL	Dec 24, 2002	Substantially Equivalent	Fournitures Hospitalieres Industrie
K023115	ACE VERSANAIL	Dec 18, 2002	Substantially Equivalent	DePuy Orthopaedics, Inc.
K023267	T2 SUPRACONDYLAR NAIL SYSTEM	Dec 11, 2002	Substantially Equivalent	Howmedica Osteonics Corp.
K023437	FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAIL	Nov 14, 2002	Substantially Equivalent	Disco-O-Tech Medical Technologies, Ltd.
K022632	SIGN IM NAIL	Sep 23, 2002	Substantially Equivalent	Surgical Implant Generation Network (Sign)
K022481	S2 TIBIAL NAIL	Aug 26, 2002	Substantially Equivalent	Howmedica Osteonics Corp.
K021786	TITANIUM ANKLE ARTHRODESIS NAIL	Aug 26, 2002	Substantially Equivalent	Biomet, Inc.
K022461	S2 FEMORAL NAIL	Aug 22, 2002	Substantially Equivalent	Howmedica Osteonics
K022225	VECTOR MEDICAL, INC., VECTOR TARGETING SYSTEM	Jul 25, 2002	Substantially Equivalent	Vector Medical, Inc.
K021744	T2 FEMORAL NAIL	Jun 26, 2002	Substantially Equivalent	Howmedica Osteonics Corp.
K021008	ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL	Jun 20, 2002	Substantially Equivalent	Advanced Orthopaedic Solutions, Inc.
K020962	G4 SLEEVED NAIL	May 24, 2002	Substantially Equivalent	Biomet Manufacturing, Inc.
K021324	FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM)	May 23, 2002	Substantially Equivalent	Disco-O-Tech Medical Technologies, Ltd.
K020562	APEX INTRAMEDULLARY NAIL SYSTEM	May 16, 2002	Substantially Equivalent	Magly Orthopedics, LLC
K020384	T2 ARTHRODESIS NAIL SYSTEM	May 06, 2002	Substantially Equivalent	Howmedica Osteonics Corp.
K021027	S2 TIBIAL NAIL	Apr 25, 2002	Substantially Equivalent	Howmedica Osteonics Corp.
K021026	S2 FEMORAL NAIL	Apr 25, 2002	Substantially Equivalent	Howmedica Osteonics Corp.
K020773	LONG LENGTH GAMMA NAIL	Apr 04, 2002	Substantially Equivalent	Howmedica Osteonics Corp.
K020677	GAMMA 3 LAG SCREW	Mar 29, 2002	Substantially Equivalent	Howmedica Osteonics Corp.
K013923	TITANIUM RETROGRADE FEMORAL NAIL - 13 MM DIAMETER	Feb 25, 2002	Substantially Equivalent	Biomet Orthopedics, Inc.
K014220	T2 FEMORAL NAIL SYSTEM	Jan 25, 2002	Substantially Equivalent	Howmedica Osteonics Corp.
K013563	LONG TROCHANTERIC NAIL SYSTEM	Dec 27, 2001	Substantially Equivalent	DePuy Orthopaedics, Inc.
K013132	SIGN IM NAIL	Dec 20, 2001	Substantially Equivalent	Surgical Implant Generation Network (Sign)
K013616	POLARUS CAP SCREW	Dec 19, 2001	Substantially Equivalent	Acu Med, Inc.
K013449	MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM	Dec 19, 2001	Substantially Equivalent	Disc-O-Tech Medical Technologies, Ltd.
K013430	ACE BIO WIN TIBIAL NAILING SYSTEM	Dec 17, 2001	Substantially Equivalent	DePuy Orthopaedics, Inc.
K013468	LONG LENGTH DYAX NAIL	Nov 16, 2001	Substantially Equivalent	Howmedica Osteonics Corp.
K013524	TROCHANTERIC DYAX NAIL SYSTEM	Nov 14, 2001	Substantially Equivalent	Howmedica Osteonics Corp.
K012967	MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM	Oct 04, 2001	Substantially Equivalent	Disco-O-Tech Medical Technologies, Ltd.
K012190	AOS MODULAR FEMORAL NAIL	Sep 24, 2001	Substantially Equivalent	Advanced Orthopaedic Solutions, Inc.
K011857	SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM	Sep 12, 2001	Substantially Equivalent	Synthes (Usa)
K012158	MODIFICATION TO: LONG LENGTH GAMMA NAIL	Aug 01, 2001	Substantially Equivalent	Howmedica Osteonics Corp.
K011129	SIGN IM NAIL	Jul 11, 2001	Substantially Equivalent	Sign, Inc.
K010988	FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM	Jun 19, 2001	Substantially Equivalent	Disc-O-Tech Medical Technologies, Ltd.
K010901	FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B	Jun 19, 2001	Substantially Equivalent	Disc-O-Tech Medical Technologies, Ltd.
K011622	OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL NAILS WITH T2 LOCKING SCREWS	Jun 15, 2001	Substantially Equivalent	Howmedica Osteonics Corp.
K011529	T2 HUMERAL NAIL SYSTEM	Jun 12, 2001	Substantially Equivalent	Howmedica Osteonics Corp.
K010780	TROCHANTERIC NAIL	Jun 12, 2001	Substantially Equivalent	DePuy Orthopaedics, Inc.
K010322	ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)	May 02, 2001	Substantially Equivalent	Orthodyne, Inc.
K010149	WUJIN #3 FEMORAL NAIL	Apr 17, 2001	Substantially Equivalent	Biopro, Inc.
K010801	T2 FEMORAL NAIL	Apr 06, 2001	Substantially Equivalent	Howmedica Osteonics Corp.
K003797	ACE AIM TTC FUSION NAIL	Dec 15, 2000	Substantially Equivalent	DePuy Orthopaedics, Inc.
K003018	TITAN TIBIAL NAIL	Dec 15, 2000	Substantially Equivalent	Howmedica Osteonics Corp.
K002783	FIXION INTERLOCKING NAIL (FIXION IL NAIL)	Dec 05, 2000	Substantially Equivalent	Disco-O-Tech Medical Technologies, Ltd.
K002278	BROOKER FEMORAL NAILS	Oct 23, 2000	Substantially Equivalent	Biomet Orthopedics, Inc.
K002057	BROOKER TIBIA NAILS	Oct 04, 2000	Substantially Equivalent	Biomet Orthopedics, Inc.
K001938	VECTOR TARGETING SYSTEM	Aug 29, 2000	Substantially Equivalent	Vector Medical, Inc.
K992856	MAGELLAN HUMERAL INTRAMEDULLARY NAIL	Mar 10, 2000	Substantially Equivalent	Orthomatrix, Inc.
K992850	MAGELLAN TIBIAL INTRAMEDULLARY NAIL	Mar 10, 2000	Substantially Equivalent	Orthomatrix, Inc.
K993956	TITANIUM PEDIATRIC FEMORAL NAIL	Dec 20, 1999	Substantially Equivalent	Biomet, Inc.
K993603	WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW	Nov 19, 1999	Substantially Equivalent	Howmedica Osteonics Corp.
K993670	MODIFIED LONG LENGTH GAMMA NAIL	Nov 16, 1999	Substantially Equivalent	Howmedica Osteonics Corp.
K992350	PYLON INTRAMEDULLAARY NAIL SYSTEM	Sep 22, 1999	Substantially Equivalent	Alphatec Mfg., Inc.
K992063	OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY	Sep 03, 1999	Substantially Equivalent	Howmedica Osteonics Corp.
K991790	ULTIMAX ANKLE FUSION ROD SYSTEM	Aug 06, 1999	Substantially Equivalent	Encore Orthopedics, Inc.
K990717	FIXION INTRAMEDULLARY NAILING SYSTEM	Jun 02, 1999	Substantially Equivalent	Disco-O-Tech Medical Technologies, Ltd.
K990322	PERRY HUMERAL NAIL	Apr 01, 1999	Substantially Equivalent	Pioneer Surgical Technology
K990436	ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM	Mar 31, 1999	Substantially Equivalent	Biodynamic Technologies, Inc.
K990152	OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL NUT AND WASHER	Mar 15, 1999	Substantially Equivalent	Howmedica Osteonics Corp.
K984602	SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM	Mar 05, 1999	Substantially Equivalent	Syntec Scientific Corp.
K984543	SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25	Mar 01, 1999	Substantially Equivalent	Syntec Scientific Corp.
K990120	MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE	Feb 01, 1999	Substantially Equivalent	Depuy Ace Medical Co.
K984305	ZETA MULTIZONE LOCKING NAIL SYSTEM	Feb 01, 1999	Substantially Equivalent	Howmedica, Inc.
K984353	OSTEO 9MM IC TIBIAL NAIL	Dec 16, 1998	Substantially Equivalent	Osteonics Corp.
K983641	HOLLAND FEMORAL NAIL SYSTEM	Dec 04, 1998	Substantially Equivalent	Biomet, Inc.
K982958	ZETA MULTIZONE LOCKING NAIL SYSTEM	Nov 20, 1998	Substantially Equivalent	Howmedica Corp.
K983358	G/K SFN AND STN LOCKING NAILS	Nov 18, 1998	Substantially Equivalent	Howmedica, Inc.
K983339	OSTEO DYNATROC PROXIMAL FEMORAL NAIL	Oct 27, 1998	Substantially Equivalent	Osteonics Corp.
K982953	TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES	Oct 21, 1998	Substantially Equivalent	Biomet, Inc.
K982873	ZETA MULTIZONE SCN LOCKING NAIL	Oct 21, 1998	Substantially Equivalent	Howmedica Corp.
K982602	RETROGRADE ROD SYSTEM	Sep 14, 1998	Substantially Equivalent	Howmedica Corp.
K982601	OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL	Sep 14, 1998	Substantially Equivalent	Osteonics Corp.
K981309	OSTEO I-C HUMERAL NAIL SYSTEM	Jun 22, 1998	Substantially Equivalent	Osteonics Corp.
K981261	HOWMEDICA SCN NAIL	Jun 22, 1998	Substantially Equivalent	Howmedica Corp.
K981230	ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM	Jun 01, 1998	Substantially Equivalent	Biodynamic Technologies, Inc.
K980609	SEGMENTAL DEFECT REPLACEMENT SYSTEM	May 18, 1998	Substantially Equivalent	Metagen, LLC
K980102	BTI HUMERAL INTRAMEDULLARY ROD SYSTEM	Apr 03, 1998	Substantially Equivalent	Biodynamic Technologies, Inc.
K974720	HOWMEDICA(R) FULLY THREADED SCREWS	Mar 13, 1998	Substantially Equivalent	Howmedica, Inc.
K974781	DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL	Mar 10, 1998	Substantially Equivalent	Depuy, Inc.
K973944	ORTHOFIX FEMORAL NAILING SYTEM	Dec 19, 1997	Substantially Equivalent	Orthofix Srl
K972813	GAMMA LOCKING NAIL SYSTEM	Oct 09, 1997	Substantially Equivalent	Howmedica Corp.
K972811	HOWMEDICA FULLY THREADED SCREWS	Oct 06, 1997	Substantially Equivalent	Howmedica Corp.
K971056	MAGELLAN MAGNETIC DISTAL TARGETING SYSTEM(PROPOSED NAME), PRODUCT LINE EXTENSION	Oct 03, 1997	Substantially Equivalent	Wrightmedicaltechnologyinc
K972692	MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL	Sep 19, 1997	Substantially Equivalent	Zimmer, Inc.
K972183	DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL	Aug 26, 1997	Substantially Equivalent	Ace Medical Co.
K972108	ALTA INTRAMEDULLARY ROD SYSTEM	Aug 12, 1997	Substantially Equivalent	Howmedica Corp.
K964444	QUICKLOCK ORTHOPAEDIC TARGETING SYSTEM	Aug 11, 1997	Substantially Equivalent	Rdh Medical
K971816	ATLAS FRACTURE PROXIMAL HUMERAL NAIL	Jul 18, 1997	Substantially Equivalent	Biomet, Inc.
K971135	MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM	Jun 05, 1997	Substantially Equivalent	Wrightmedicaltechnologyinc
K970280	FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTEROAM FRACTURES	May 22, 1997	Substantially Equivalent	Ferguson Medical
K970257	FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES	May 22, 1997	Substantially Equivalent	Ferguson Medical
K970897	BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM	Apr 21, 1997	Substantially Equivalent	Biodynamic Technologies, Inc.
K970202	DEPUY ACE AIM TITANIUM TIBIAL NAIL	Mar 21, 1997	Substantially Equivalent	Depuy Ace Medical Co.
K961360	TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM	Mar 13, 1997	Substantially Equivalent	Encore Orthopedics, Inc.
K965098	INTRAMEDULLARY NAIL SYSTEM	Feb 28, 1997	Substantially Equivalent	Zimmer, Inc.
K964163	TRIMAX NAIL SYSTEM	Dec 27, 1996	Substantially Equivalent	Smith & Nephew Richards, Inc.
K964243	HUMERUS WIRES	Dec 05, 1996	Substantially Equivalent	Compagnie Financiere & Medicale (Cf&M)
K963026	TBD	Oct 28, 1996	Substantially Equivalent	Acu Med, Inc.
K963077	TBD	Oct 01, 1996	Substantially Equivalent	Acu Med, Inc.
K962561	SUPRACONDYLAR INTRAMEDULLARY NAIL	Sep 25, 1996	Substantially Equivalent	Zimmer, Inc.
K962552	EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM	Sep 25, 1996	Substantially Equivalent	Biodynamic Technologies, Inc.
K962553	EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM	Aug 28, 1996	Substantially Equivalent	Biodynamic Technologies, Inc.
K962091	POLARUS AF ROD	Jul 24, 1996	Substantially Equivalent	Acu Med, Inc.
K961027	ORTHOFIX TIBIAL NAILING SYSTEM	May 08, 1996	Substantially Equivalent	Orthofix, Inc.
K960524	ALTA CFX IM ROD SYSTEM	Mar 22, 1996	Substantially Equivalent	Howmedica Corp.
K955761	TIBIA ORTHONAIL	Mar 13, 1996	Substantially Equivalent	Orthologic Corp.
K932330	TI-6AL-7NB URTN	Mar 08, 1996	Substantially Equivalent	Synthes (Usa)
K954756	FIXANO I.F.O (INTERLOCKING FLEXIBLE OSTEOSYNTHESIS) SYSTEM	Jan 25, 1996	Substantially Equivalent	Ferguson Medical
K954554	ALTA TIBIAL/HUMERAL ROD	Dec 13, 1995	Substantially Equivalent	Howmedica Corp.
K953334	SYNTHES FLEXNAIL	Oct 31, 1995	Substantially Equivalent	Synthes (Usa)
K952923	INTRAMEDULLARY COMPRESSION ARTHRODESIS (ICA) NAIL	Sep 29, 1995	Substantially Equivalent	Howmedica Corp.
K952739	ORTHONAIL	Sep 15, 1995	Substantially Equivalent	Orthologic Corp.
K951740	INTRAMEDULARY FIXATION ROD	Aug 11, 1995	Substantially Equivalent	Acu Med, Inc.
K952534	TENTATIVELY POLARUS EX ROD	Jul 13, 1995	Substantially Equivalent	Acu-Med, Inc.
K951673	ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES	Jul 06, 1995	Substantially Equivalent	Acu Med, Inc.
K950394	TIBIA-TALUS-CALCANEUS NAIL	May 19, 1995	Substantially Equivalent	Smith & Nephew Richards, Inc.
K935383	FEMROD AND FEMROD RECON INSERT	Mar 21, 1995	Substantially Equivalent	Applied Osteo Systems, Inc.
K933995	TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION	Jan 27, 1995	Substantially Equivalent	Applied Osteo Systems, Inc.
K944501	TRUE/FLEX INTRAMEDULLARY ROD END-CAP	Nov 28, 1994	Substantially Equivalent	Applied Osteo Systems, Inc.
K935295	ALTA FEMORAL INTRAMEDULLARY RODS/CFX RODS MODIFICATION	Oct 11, 1994	Substantially Equivalent	Howmedica Corp.
K933340	OSTEO INTERLOCKING-COMPRESSION NAIL	Jun 30, 1994	Substantially Equivalent	Osteo AG
K930972	INTRAMEDULLARY SYSTEMS	Mar 29, 1994	Substantially Equivalent	Baumer Ortopedia , Ltd.
K934962	AIM SUPRACONDYLAR NAIL	Mar 22, 1994	Substantially Equivalent	Ace Orthopedic Manufacturing Co.
K934643	ACE HUMERAL NAIL	Mar 22, 1994	Substantially Equivalent	Ace Orthopedic Manufacturing Co.
K933518	SYNTHES UNREAMED HUMERAL NAIL (URHN)	Mar 14, 1994	Substantially Equivalent	Synthes (Usa)
K932593	ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL	Mar 10, 1994	Substantially Equivalent	Synthes (Usa)
K934148	TRUE/FLEX CLAVICLE RODS	Feb 22, 1994	Substantially Equivalent	Applied Osteo Systems, Inc.
K933361	ACUMED RADIUS ROD	Feb 22, 1994	Substantially Equivalent	Acu Med, Inc.
K933027	THE MODULAR NAIL	Feb 22, 1994	Substantially Equivalent	Smith & Nephew Richards, Inc.
K931256	SEIDEL HUMERAL LOCKING NAIL	Jul 02, 1993	Substantially Equivalent	Howmedica Corp.
K926232	ALTA CFX ROD SYSTEM	Jun 17, 1993	Substantially Equivalent	Howmedica Corp.
K926213	MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM	Jun 17, 1993	Substantially Equivalent	Osteo Technology, Inc.
K925544	SEIDEL HUMERAL LOCKING NAIL & ADDITIONAL LENGTHS	Mar 04, 1993	Substantially Equivalent	Howmedica Corp.
K923597	SYNTHES TITANIUM UNREAMED FEMORAL NAIL	Jan 21, 1993	Substantially Equivalent	Synthes (Usa)
K923580	SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL	Jan 21, 1993	Substantially Equivalent	Synthes (Usa)
K924656	TRUE/ FLEX FIBULA RODS	Nov 24, 1992	Substantially Equivalent	Applied Osteo Systems, Inc.
K922266	ALTA FEMORAL INTRAMEDULLARY ROD SYSTEM, ADD SIZES	Sep 21, 1992	Substantially Equivalent	Howmedica Corp.
K920666	INTRAMEDULARY FIXATION ROD	Aug 05, 1992	Substantially Equivalent	Acu Med, Inc.
K922196	OSTEO TIBIA NAIL	Jul 23, 1992	Substantially Equivalent	Osteo AG
K922195	OSTEO FEMORAL NAIL	Jul 23, 1992	Substantially Equivalent	Osteo AG
K920598	TRUE/FLEX HUMERUS CAP	Apr 28, 1992	Substantially Equivalent	Applied Osteo Systems, Inc.
K915435	INTERLOCKING TIBIAL NAILING SYSTEM	Mar 02, 1992	Substantially Equivalent	Stryker Corp.
K913949	TRUE/FLEX HUMERUS, ULNA & RADIUS INTRAMED RODS SYS	Jan 17, 1992	Substantially Equivalent	Applied Osteo Systems, Inc.
K912930	INTERLOCKING FEMORAL NAILING SYSTEM	Jan 13, 1992	Substantially Equivalent	Stryker Corp.
K912710	TRUE/FLEX TIBIAL RODS WITH CAP	Oct 15, 1991	Substantially Equivalent	Applied Osteo Systems, Inc.
K912420	ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM	Sep 23, 1991	Substantially Equivalent	Scientific Research
K911554	AIM TIBIAL NAIL	Jul 08, 1991	Substantially Equivalent	Ace Medical Co.
K903526	ALTA(R) PFX IM ROD	Mar 05, 1991	Substantially Equivalent	Howmedica Corp.
K903256	HANSEN-STREET TYPE INTRAMEDULLARY NAIL	Jul 30, 1990	Substantially Equivalent	Onyx Medical Corp.
K902264	TRUE/FLEX HUMERUS, ULNA AND RADIUS INTRAMEDULLARY	Jul 12, 1990	Substantially Equivalent	Applied Osteo Systems, Inc.
K893377	RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS	Nov 16, 1989	Substantially Equivalent	Richards Medical Co., Inc.
K890936	ALTA HOLLOW TIBIAL RODS	Jun 05, 1989	Substantially Equivalent	Howmedica Corp.
K884500	ALTA NON-REAMED TIBIAL ROD	Jan 18, 1989	Substantially Equivalent	Howmedica Corp.
K884610	INTERLOCKING INTRAMEDULLARY NAILS	Dec 01, 1988	Substantially Equivalent	Depuy, Inc.
K884407	TRACER SKELETAL TRACTION PINS	Nov 28, 1988	Substantially Equivalent	De Medica Mfg., Inc.
K882443	ZINDRICK IM ROD INSTRUMENTS	Jun 30, 1988	Substantially Equivalent	Buckman Co., Inc.
K880737	SELF GUIDING (SG) INTERLOCKING NAIL	Mar 14, 1988	Substantially Equivalent	Orthopaedic Designs, Inc.
K871539	ZINDRICK IM ROD	Aug 17, 1987	Substantially Equivalent	Buckman Co., Inc.
K871947	MODIFIED HUCKSTEP INTRAMEDULLARY NAIL	Aug 05, 1987	Substantially Equivalent	Downs Surgical , Ltd.
K871814	SARMIENTO FOREARM NAIL	Jun 30, 1987	Substantially Equivalent	Depuy, Inc.
K871872	HI MARC INTERLOCKING NAIL	Jun 23, 1987	Substantially Equivalent	Depuy, Inc.
K871608	RODRIGUEZ NAIL	May 08, 1987	Substantially Equivalent	Richards Medical Co., Inc.
K870040	INTRAMEDULLARY NAIL	Mar 26, 1987	Substantially Equivalent	The Deca Co.
K861365	FASICULATED NAIL	May 06, 1986	Substantially Equivalent	Lake Region Mfg., Inc.
K860756	GROSSE AND KEMPF LOCKING NAIL SYSTEM, NON-SLOT ROD	Mar 28, 1986	Substantially Equivalent	Howmedica Corp.
K860592	ACE IM ROD	Mar 19, 1986	Substantially Equivalent	Buckman Co., Inc.
K853250	FEMOROTIBIAL MEDULLARY NAIL	Feb 12, 1986	Substantially Equivalent	Zimmer, Inc.
K854227	FASCILULATED NAIL	Feb 04, 1986	Substantially Equivalent	The Deca Co.
K854338	KIRSCHNER INTRAMEDULLARY NAIL SYSTEM	Dec 09, 1985	Substantially Equivalent	Kirschner Medical Corp.
K852020	INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI	May 22, 1985	Substantially Equivalent	Warsaw Orthopedic, Inc.
K850441	MEC INTRAMEDULLARY ROD	Apr 19, 1985	Substantially Equivalent	Pfizer, Inc.
K850142	ACE INTRAMEDULLARY ROD FOR SMALL BONES	Feb 07, 1985	Substantially Equivalent	Buckman Co., Inc.
K830087	INTRAMEDULLARY ROD	Mar 01, 1983	Substantially Equivalent	The Deca Co.
K820852	MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY	Apr 15, 1982	Substantially Equivalent	Serrano Intl.
K813371	GROSSE AND KEMPF LOCKING NAIL SYS.	Mar 01, 1982	Substantially Equivalent	Howmedica Corp.
K811002	ENDER PINS	Apr 29, 1981	Substantially Equivalent	Richard'S Medical Equip., Inc.
K810957	MARCOVE INTRAMEDULLARY ROD	Apr 17, 1981	Substantially Equivalent	Hexcel Medical
K810956	MARCOVE HUMERAL ROD	Apr 17, 1981	Substantially Equivalent	Hexcel Medical
K810535	MOURADIAN MODIFIED ZICKEL HUMERAL ROD	Mar 13, 1981	Substantially Equivalent	Howmedica Corp.
K803106	AGINSKY NAIL	Feb 12, 1981	Substantially Equivalent	Cintor Orthopaedic Div.
K803196	FLEXIBLE PIN S SHAPED INTRAMED. SYSTEM	Feb 09, 1981	Substantially Equivalent	Howmedica Corp.
K801010	KIRSCHNER WIRE	May 20, 1980	Substantially Equivalent	American Safety Equipment Corp.
K792203	CURVED KUNTSCHER INTRAMEDULLARY NAIL	Dec 05, 1979	Substantially Equivalent	Howmedica Corp.
K772081	NAIL, INTRAMEDULLARY, FLEXIBLE	Nov 11, 1977	Substantially Equivalent	Depuy, Inc.