Product Code: JEY FDA class 2 21 CFR 872.4760

Plate, Bone

Dental

A Dental Bone Plate is a surgical implant used in oral and maxillofacial surgery to stabilize and fix fractured or osteotomized bone segments of the jaw, providing rigid internal fixation to support healing. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and adherence to general and special controls. The product code is JEY, regulated under 21 CFR 872.4760, within the Dental medical specialty. This device is flagged as an implant reflecting its placement within osseous tissue.

View on FDA

510(k)s

292

FEI Numbers

106

Registration Numbers

106

Unique Applicants

107

Years Active

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Basic Information

Product Code: JEY
Device Class: FDA class 2
Regulation Number: 872.4760
Medical Specialty: Dental
Review Panel: DE
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 292 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252246	Leforte MMF System	Apr 02, 2026	Substantially Equivalent	Jeil Medical Corporation
K253373	Southern Craniomaxillofacial (CMF) System	Dec 19, 2025	Substantially Equivalent	Southern Medical (Pty) , Ltd.
K251441	Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System	Nov 07, 2025	Substantially Equivalent	Inion OY
K241314	KLS Martin Oral-Max Implants MR Conditional (bundled)	Aug 16, 2024	Substantially Equivalent	KLS-Martin L.P.
K240651	MRI Universal	Jul 12, 2024	Substantially Equivalent	Stryker Leibinger GmbH & Co KG
K233874	tmCMF Solution	Jul 11, 2024	Substantially Equivalent	Techmah Cmf
K232889	METICULY Patient-specific titanium maxillofacial mesh implant	Apr 30, 2024	Substantially Equivalent	Meticuly Co., Ltd.
K232350	Stryker Facial iD System	Jan 13, 2024	Substantially Equivalent	Stryker Craniomaxillofacial
K230398	MedCAD® AccuPlate® 3DTi Patient-Specific Plating System	Sep 26, 2023	Substantially Equivalent	Medcad
K230733	Stryker Resorbable Fixation System	Aug 05, 2023	Substantially Equivalent	Stryker Leibinger GmbH & Co KG
K222650	Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate	Dec 09, 2022	Substantially Equivalent	Stryker Craniomaxillofacial (Cmf)
K220360	Tandry CMF Plate System	Nov 10, 2022	Substantially Equivalent	Microware Precision Co., Ltd.
K221855	Universal CMF System	Nov 09, 2022	Substantially Equivalent	Stryker Leibinger GmbH & Co KG
K210731	KLS Martin Individual Patient Solutions	Jul 18, 2022	Substantially Equivalent	KLS-Martin L.P.
K213777	Stryker Resorbable Fixation System	Feb 04, 2022	Substantially Equivalent	Stryker Leibinger Micro Implants
K202969	Biomet Microfixation OmniMax MMF System	Aug 05, 2021	Substantially Equivalent	Biomet Microfixation
K202918	OsteoSync Ti Dental Mesh	Jul 14, 2021	Substantially Equivalent	Sites Medical, LLC
K203282	TECHFIT Patient-Specific Maxillofacial System	May 19, 2021	Substantially Equivalent	Industrias Medicas Sampedro S.A.S
K193280	MedCAD® AccuPlate® Patient-Specific Plate	Feb 12, 2021	Substantially Equivalent	Medcad
K201944	DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)	Sep 10, 2020	Substantially Equivalent	Synthes (USA) Products, LLC
K182759	BoniPlus Dental G-Mesh System	Jul 29, 2020	Substantially Equivalent	Montjade Engineering Co., Ltd.
K192747	Yxoss CBR®	Jun 17, 2020	Substantially Equivalent	Reoss GmbH
K191997	FAICO CMF System	Apr 22, 2020	Substantially Equivalent	Faico Medical, LLC
K193143	Stryker Facial iD Plating System	Mar 26, 2020	Substantially Equivalent	Stryker
K193136	Stryker Customized Mandible Recon Plate Kit	Mar 26, 2020	Substantially Equivalent	Stryker
K192655	Depuy Synthes Maxillofacial Portfolio - MR Conditional	Dec 30, 2019	Substantially Equivalent	Synthes (USA) Products, LLC
K182758	MCI - CMF System	Dec 05, 2019	Substantially Equivalent	Mci Medical Concept Innovation, Inc.
K191028	KLS Martin Individual Patient Solutions	Nov 22, 2019	Substantially Equivalent	KLS-Martin L.P.
K190696	Stryker Surgeon iD Mandible Recon Plate	Jun 28, 2019	Substantially Equivalent	Stryker
K182609	Delphos Implants Rigid Fixation System	Mar 29, 2019	Substantially Equivalent	Delphos Implants - Ind.Com. Importacao E Exportacao DE
K182305	Stryker Facial iD Plating System	Jan 07, 2019	Substantially Equivalent	Stryker
K180204	CranioMaxillofacial Fixation (CMF) System - CMF Visionare	Dec 28, 2018	Substantially Equivalent	Visionare, LLC
K180249	OmniPore DUROMAX Surgical Implants	Oct 11, 2018	Substantially Equivalent	Matrix Surgical Holdings, LLC/Matrix Surgical USA
K180962	KLS Martin Individual Patient Solutions	Aug 13, 2018	Substantially Equivalent	KLS-Martin L.P.
K173039	TruMatch CMF Titanium 3D Printed Implant	Jul 10, 2018	Substantially Equivalent	Materialise NV
K170697	GBR system	May 24, 2018	Substantially Equivalent	Surgident
K172354	OssBuilder System	Mar 26, 2018	Substantially Equivalent	Osstem Implant Co., Ltd.
K173320	KLS Martin L1 MMF System	Feb 23, 2018	Substantially Equivalent	KLS Martin L.P.
K163579	KLS Martin Individual Patient Solutions	Nov 21, 2017	Substantially Equivalent	KLS Martin L.P.
K170773	Stryker Universal Mesh	Nov 08, 2017	Substantially Equivalent	Stryker
K172572	Stryker Upper-Face AXS screws and Mid-Face AXS screws	Oct 31, 2017	Substantially Equivalent	Stryker
K170272	TruMatch CMF Titanium 3D Printed Implant System	Aug 08, 2017	Substantially Equivalent	Materialise NV
K171364	MP LeFort I Plates	Jul 24, 2017	Substantially Equivalent	Stryker
K160363	OPTIMUS CMF SYSTEM	Oct 20, 2016	Substantially Equivalent	Osteonic Co., Ltd.
K152326	Biomet Microfixation OmniMax MMF System	Dec 10, 2015	Substantially Equivalent	Biomet Microfixation
K150965	LeForte System II	Sep 17, 2015	Substantially Equivalent	Jeil Medical Corporation
K143730	GBR System	Jun 10, 2015	Substantially Equivalent	Jeil Medical Corporation
K142568	Stryker MEDPOR TITAN 3D Orbital Floor Implant	May 05, 2015	Substantially Equivalent	Stryker
K143338	Argulated Locking Plates	Apr 01, 2015	Substantially Equivalent	Osteomed LP
K143336	Biomet Microfixation OmniMax MMF System	Apr 01, 2015	Substantially Equivalent	Biomet Microfixation
K140037	OPTIMUS CMF SYSTEM	Jan 20, 2015	Substantially Equivalent	Osteonic Co., Ltd.
K141764	TRISTAR BONE GRAFT FIXATION SYSTEM	Dec 18, 2014	Substantially Equivalent	Impladent , Ltd.
K140978	OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM	Dec 18, 2014	Substantially Equivalent	Osteomed
K141165	MATRIXWAVE MMF SYSTEM	Oct 17, 2014	Substantially Equivalent	Synthes (USA) Products, LLC
K133461	STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM	Aug 01, 2014	Substantially Equivalent	Stryker
K133304	RXG DISTRACTION SYSTEM	May 15, 2014	Substantially Equivalent	KLS-Martin L.P.
K121235	LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM	Jan 09, 2014	Substantially Equivalent	Stryker
K132519	STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT	Dec 06, 2013	Substantially Equivalent	Stryker
K132600	FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING	Oct 02, 2013	Substantially Equivalent	Biomet Microfixation
K131289	I-GEN	Sep 25, 2013	Substantially Equivalent	Megagen Implant Co., Ltd.
K130840	SMARTBUILDER SYSTEM (SB1)	Sep 18, 2013	Substantially Equivalent	Osstem Implant Co., Ltd.
K131674	PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING	Aug 08, 2013	Substantially Equivalent	Biomet Microfixation
K123786	STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM	Apr 09, 2013	Substantially Equivalent	Stryker
K122647	SYNTHES PATIENT SPECIFIC PLATE	Feb 28, 2013	Substantially Equivalent	Synthes, Inc.
K122890	INION CPS ORBITAL PLATES	Jan 29, 2013	Substantially Equivalent	Inion OY
K113567	SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM	Nov 19, 2012	Substantially Equivalent	Synthes, Inc.
K122313	STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM	Oct 31, 2012	Substantially Equivalent	Stryker
K120951	SMARTBUILDER SYSTEM	Oct 03, 2012	Substantially Equivalent	Osstem Implant Co., Ltd.
K121589	BIOMET MICROFIXATION FACIAL PLATING SYSTEM	Sep 21, 2012	Substantially Equivalent	Biomet Microfixation
K121574	SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM	Jun 29, 2012	Substantially Equivalent	Synthes, Inc.
K113512	BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM	Jun 29, 2012	Substantially Equivalent	Biomet Microfixation
K120271	ARTISAN SPACE MAINTENANCE SYSTEM	May 30, 2012	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K112457	LEFORTE SYSTEM BONE PLATE & SCREW	May 18, 2012	Substantially Equivalent	Arkin Consulting Group
K112064	RESORB X-G	Mar 23, 2012	Substantially Equivalent	KLS-Martin L.P.
K111761	NEO TITANIUM MESH, CTI-MEM	Jan 10, 2012	Substantially Equivalent	Neobiotech Co., Ltd.
K113251	SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES	Dec 21, 2011	Substantially Equivalent	Synthes, Inc.
K110926	BONE PLATE; BONE SCREW	Dec 08, 2011	Substantially Equivalent	Biomaterials Korea, Inc.
K110259	ARCHITEX SPACE MAINTENANCE SYSTEM	Apr 13, 2011	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K103136	SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE	Mar 18, 2011	Substantially Equivalent	Materialise NV
K103778	LEFORTE NEURO SYSTEM BONE PLATE	Jan 26, 2011	Substantially Equivalent	Jeil Medical Corporation
K102656	SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM	Dec 20, 2010	Substantially Equivalent	Synthes (Usa)
K102641	MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE	Dec 20, 2010	Substantially Equivalent	Neoortho Produtos Ortopedicos S/A
K100779	SUSTAIN SPACE MAINTENANCE SYSTEM	Dec 13, 2010	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K091807	MEDPOR FIXATION SYSTEM	Jun 28, 2010	Substantially Equivalent	Porex Surgical, Inc.
K091812	FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS	May 07, 2010	Substantially Equivalent	Frontier Devices, Inc.
K092743	THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM	Jan 15, 2010	Substantially Equivalent	Stryker Craniomaxillofacial
K091233	SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES	Dec 11, 2009	Substantially Equivalent	Synthes (Usa)
K091679	LEFORTE SYSTEM BONE PLATE	Oct 02, 2009	Substantially Equivalent	Jeil Medical Corporation
K091144	SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES	Aug 25, 2009	Substantially Equivalent	Synthes (Usa)
K083388	SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM	Mar 12, 2009	Substantially Equivalent	Synthes (Usa)
K082335	SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM	Nov 10, 2008	Substantially Equivalent	Synthes (Usa)
K073307	MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM	Oct 29, 2008	Substantially Equivalent	Bio-Technology USA, Inc.
K082757	MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM	Oct 01, 2008	Substantially Equivalent	Bioplate, Inc.
K080862	SONICWELD RX (RESORB-X)	Jul 21, 2008	Substantially Equivalent	KLS-Martin L.P.
K080694	OSTEOMED MODULAR LOCKING FIXATION SYSTEM	May 15, 2008	Substantially Equivalent	Osteomed LP
K081067	FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)	May 09, 2008	Substantially Equivalent	Biomet Microfixation, Inc.
K080331	SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM	Apr 30, 2008	Substantially Equivalent	Synthes (Usa)
K072528	ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES	Dec 28, 2007	Substantially Equivalent	Prosurg, Inc.
K072463	SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM	Nov 29, 2007	Substantially Equivalent	Satyrne Medical
K071612	MODUS TRILOCK 2.0/2.3/2.5	Sep 11, 2007	Substantially Equivalent	Medartis AG
K062436	SIS SINUS IMPLANT STABILIZER	Jul 30, 2007	Substantially Equivalent	Mondeal Medical Systems GmbH
K070737	XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES	Jul 25, 2007	Substantially Equivalent	Prosurg, Inc.
K063790	THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM	Apr 16, 2007	Substantially Equivalent	Synthes (Usa)
K061881	OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM	Mar 14, 2007	Substantially Equivalent	Takiron Co., Ltd.
K062789	SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM	Feb 27, 2007	Substantially Equivalent	Synthes (Usa)
K063052	LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES	Jan 12, 2007	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K061507	SONICWELD RX ENDOBROW FIXATION	Sep 21, 2006	Substantially Equivalent	KLS-Martin L.P.
K060177	KLS MARTIN RIGID FIXATION - STERILE	Apr 18, 2006	Substantially Equivalent	KLS Martin L.P.
K060492	AESCULAP CRANIOFACIAL PLATE AND SCREW	Apr 07, 2006	Substantially Equivalent	Aesculap, Inc.
K052444	INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM	Sep 20, 2005	Substantially Equivalent	Inion , Ltd.
K051236	RESORB-X SF	Aug 22, 2005	Substantially Equivalent	KLS-Martin L.P.
K051845	THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM	Jul 27, 2005	Substantially Equivalent	Bioplate, Inc.
K051293	CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM	Jun 14, 2005	Substantially Equivalent	Ceremed , Inc.
K051341	INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059	May 27, 2005	Substantially Equivalent	Inion , Ltd.
K050669	JEIL BONE FIXATION SYSTEM	May 26, 2005	Substantially Equivalent	Jeil Medical Corporation
K050608	SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM	May 18, 2005	Substantially Equivalent	Synthes (Usa)
K050934	MODUS TITANIUM OSTEOSYNTHESIS SYSTEM	May 05, 2005	Substantially Equivalent	Medartis, Inc.
K050204	SYNTHES RAPID RESORBABLE TACK SYSTEM	Mar 04, 2005	Substantially Equivalent	Synthes (Usa)
K043297	MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM	Feb 23, 2005	Substantially Equivalent	Medicon EG
K042987	MODIFICATION TO SYNTHES CRANIAL PLATES	Nov 23, 2004	Substantially Equivalent	Synthes (Usa)
K042365	SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM	Nov 18, 2004	Substantially Equivalent	Synthes (Usa)
K042517	BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS	Oct 08, 2004	Substantially Equivalent	Linvatec Biomaterials, Ltd.
K040650	BONAMATES SERIES	Jun 03, 2004	Substantially Equivalent	Biotech One, Inc.
K030425	LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER	May 14, 2004	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K033092	THE GNATHOMETER	Apr 21, 2004	Substantially Equivalent	Ortho Gnathics, LLC
K030989	OSTEOSORB TACK FIXATION SYSTEM	Apr 01, 2004	Substantially Equivalent	Noviace Corporation
K040272	SYNTHES (USA) CRANIOFACIAL PLATES	Feb 23, 2004	Substantially Equivalent	Synthes (Usa)
K032520	ORTRAUTEK TRAUMA SYSTEM	Nov 12, 2003	Substantially Equivalent	Tekka
K033194	INION CPS BABY 1.5 BIOABSORBABLE SYSTEM	Oct 30, 2003	Substantially Equivalent	Inion , Ltd.
K031989	ORTRAUTEK ORTHOGNATHIC SYSTEM	Oct 28, 2003	Substantially Equivalent	Tekka
K033121	1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES	Oct 20, 2003	Substantially Equivalent	Synthes (Usa)
K033160	SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES	Oct 09, 2003	Substantially Equivalent	Synthes (Usa)
K031659	UNIVERSAL NEURO SYSTEM	Sep 10, 2003	Substantially Equivalent	Stryker Instruments
K031761	SYNTHES (USA) NEW/STERIAL ORBITAL PLATES	Sep 03, 2003	Substantially Equivalent	Synthes (Usa)
K030448	OSTEOMED 2.0 LOCKING PLATES AND SCREWS	May 09, 2003	Substantially Equivalent	Osteomed LP
K031028	THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY	Apr 28, 2003	Substantially Equivalent	Bioplate, Inc.
K030806	BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY	Apr 08, 2003	Substantially Equivalent	Bioplate, Inc.
K030069	SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM	Apr 08, 2003	Substantially Equivalent	Synthes (Usa)
K022035	OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB	Jan 17, 2003	Substantially Equivalent	Osteomedics, Inc.
K022844	SYNTHES RESORBABLE CONTOURABLE MESH	Jan 07, 2003	Substantially Equivalent	Synthes (Usa)
K022185	UNIVERSAL CMF SYSTEM	Dec 17, 2002	Substantially Equivalent	Stryker Instruments
K023810	MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY	Dec 04, 2002	Substantially Equivalent	Bioplate, Inc.
K023665	MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY	Nov 22, 2002	Substantially Equivalent	Bioplate, Inc.
K022012	SYNTHES LOW PROFILE NEURO SYSTEM	Nov 01, 2002	Substantially Equivalent	Synthes (Usa)
K023488	OSSTAPLE, CRANIOFACIAL	Oct 31, 2002	Substantially Equivalent	Biomedical Enterprises, Inc.
K023486	OSSTAPLE, MAXILLOFACIAL	Oct 31, 2002	Substantially Equivalent	Biomedical Enterprises, Inc.
K022890	MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY	Sep 06, 2002	Substantially Equivalent	Bioplate, Inc.
K021928	SYNTHES (USA) RESORBABLE FIXATION SYSTEM	Sep 06, 2002	Substantially Equivalent	Synthes (Usa)
K022005	SYNTHES MIDFACE DISTRACTOR	Sep 03, 2002	Substantially Equivalent	Synthes (Usa)
K021642	SYNTHES CRANIOFACIAL PLATES	Aug 14, 2002	Substantially Equivalent	Synthes (Usa)
K021618	OSA RIGID INTERNAL FIXATION SYSTEM	Aug 08, 2002	Substantially Equivalent	Osteomed Corp.
K021511	CYTOFLEX MESH	Aug 06, 2002	Substantially Equivalent	Unicare Biomedical, Inc.
K021342	NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR	Aug 01, 2002	Substantially Equivalent	Osteomedics, Inc.
K021341	NORMED BONE TRANSPORT DISTRACTION DEVICE	Aug 01, 2002	Substantially Equivalent	Osteomedics, Inc.
K022033	STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM	Jul 19, 2002	Substantially Equivalent	Bioplate, Inc.
K021684	THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY	Jun 26, 2002	Substantially Equivalent	Bioplate, Inc.
K021382	SYNTHES (USA) AUTOMATED TACK DRIVER	May 16, 2002	Substantially Equivalent	Synthes (Usa)
K020505	SYNTHES TRANSLATING MAXILLARY DISTRACTOR	Apr 23, 2002	Substantially Equivalent	Synthes (Usa)
K013672	BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM	Apr 08, 2002	Substantially Equivalent	Azary Technologies, LLC
K011590	RESORB-X RESORBABLE PLATING SYSTEM	Mar 20, 2002	Substantially Equivalent	KLS-Martin L.P.
K014263	NEWGEN/UNIVERSAL MANDIBULAR SYSTEM	Mar 08, 2002	Substantially Equivalent	Stryker Instruments
K011569	BIOSORBFX O/M 2.0/2/4 SYSTEM	Feb 22, 2002	Substantially Equivalent	Bionx Implants, Inc.
K020087	SYNTHES CRANIAL PLATES	Feb 20, 2002	Substantially Equivalent	Synthes (Usa)
K013055	THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM	Dec 07, 2001	Substantially Equivalent	Bioplate, Inc.
K012910	THE BIOPLATE MANDIBLE FIXATION SYSTEM	Nov 20, 2001	Substantially Equivalent	Bioplate, Inc.
K013039	INION CPS 2.0 ORTHOGNATHIC PLATE	Oct 05, 2001	Substantially Equivalent	Inion , Ltd.
K012413	MACROPORE FX, PS, NS, LP	Sep 18, 2001	Substantially Equivalent	Macropore Biosurgery, Inc.
K011698	STRAUMANN GBR SYSTEM	Aug 23, 2001	Substantially Equivalent	Institut Straumann AG
K010118	NORMED MANDIBULAR FIXATION SYSTEM	Aug 14, 2001	Substantially Equivalent	Osteomedics, Inc.
K003281	LACTOSORB RAPIDFLAP	Aug 07, 2001	Substantially Equivalent	Biomet, Inc.
K002207	MACROPOREPX PEDIATRIC SYSTEM	Jul 11, 2001	Substantially Equivalent	Macropore Biosurgery, Inc.
K011380	MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM	May 14, 2001	Substantially Equivalent	Bioplate, Inc.
K010499	SYNTHES (USA) MIDFACE DISTRACTOR	May 03, 2001	Substantially Equivalent	Synthes (Usa)
K010351	INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM	Mar 15, 2001	Substantially Equivalent	Inion , Ltd.
K010687	BIOSORBFX AND BIOSORBPDX MESH	Mar 14, 2001	Substantially Equivalent	Bionx Implants, Inc.
K010352	CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM	Mar 14, 2001	Substantially Equivalent	Inion , Ltd.
K003786	SMF RESORBABLE MESHES AND SHEETS	Feb 27, 2001	Substantially Equivalent	Synthes (Usa)
K003549	CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS	Feb 15, 2001	Substantially Equivalent	Codman & Shurtleff, Inc.
K002083	LORENZ RESORBABLE DISTRACTOR SYSTEM	Feb 12, 2001	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K003757	THERMOFX MESH	Feb 07, 2001	Substantially Equivalent	Bionx Implants, Ltd.
K002426	THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY	Jan 26, 2001	Substantially Equivalent	Bioplate, Inc.
K994060	THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE	Jan 24, 2001	Substantially Equivalent	Bioplate, Inc.
K003883	MOLINA ORBITAL MALAR DISTRACTOR	Jan 23, 2001	Substantially Equivalent	KLS-Martin L.P.
K003393	MAXILLARY DISTRACTOR	Jan 17, 2001	Substantially Equivalent	Synthes (Usa)
K000560	SYNTHES (USA) RESORBABLE TACK SYSTEM	Jan 09, 2001	Substantially Equivalent	Synthes (Usa)
K003756	BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES	Jan 03, 2001	Substantially Equivalent	Bionx Implants, Inc.
K003660	LEIBINGER NEURO CLIP SYSTEM	Dec 12, 2000	Substantially Equivalent	Stryker Instruments
K000594	LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE	Dec 08, 2000	Substantially Equivalent	Stryker Leibinger
K002798	CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS	Dec 06, 2000	Substantially Equivalent	Codman & Shurtleff, Inc.
K002619	NEWGEN SYSTEM	Nov 16, 2000	Substantially Equivalent	Stryker Instruments
K000696	MACROPOREMX MANDIBULAR FIXATION SYSTEM	Oct 19, 2000	Substantially Equivalent	Macropore Biosurgery, Inc.
K002879	MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM	Oct 05, 2000	Substantially Equivalent	Bioplate, Inc.
K992905	CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM	Aug 01, 2000	Substantially Equivalent	Codman & Shurtleff, Inc.
K001530	THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM	Jul 21, 2000	Substantially Equivalent	Bioplate, Inc.
K001219	MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM	Jun 21, 2000	Substantially Equivalent	Biomedical Ent., Inc.
K000836	BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM	Jun 08, 2000	Substantially Equivalent	Bionx Implants, Inc.
K001238	LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM	May 03, 2000	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K994154	MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES	Feb 15, 2000	Substantially Equivalent	KLS-Martin L.P.
K993862	MODUS SAGITTAL SPLIT PLATE	Dec 29, 1999	Substantially Equivalent	The Straumann Co.
K992683	MODUS 2.5 MANDIBULAR TRAUMA SET	Nov 24, 1999	Substantially Equivalent	Medartis AG
K992682	MODUS 2.5 MANDIBULAR RECONSTRUCTION SET	Nov 24, 1999	Substantially Equivalent	Medartis AG
K992330	THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY	Nov 23, 1999	Substantially Equivalent	Biomedics
K992158	LACTOSORB SHEETS	Aug 20, 1999	Substantially Equivalent	Biomet, Inc.
K990920	DRG TITANIUM BONE PLATE	Jun 10, 1999	Substantially Equivalent	Doctor'S Research Group, Inc.
K990140	NORMED BONE TRANSPORT	Mar 25, 1999	Substantially Equivalent	Ace Surgical Supply Co., Inc.
K983360	MACROPORE PROTECTIVE SHEET	Mar 19, 1999	Substantially Equivalent	Pacific Materials and Interfaces
K982721	BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM	Feb 17, 1999	Substantially Equivalent	Bionx Implants, Inc.
K984230	OSTEO-MESH TM-300	Feb 04, 1999	Substantially Equivalent	Osteogenics Biomedical, Inc.
K983885	BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES	Jan 29, 1999	Substantially Equivalent	Howmedica, Inc.
K983535	THE TITANIUM MINIPLATING SYSTEM, THE TITANIUM MICROPLATING SYSTEM, THE TITANIUM MEDIUMPLATING SYSTEM, MODEL #'S H12-1010	Dec 29, 1998	Substantially Equivalent	Hans Hermann GmbH
K983528	MICRO DYNAMIC MESH	Dec 23, 1998	Substantially Equivalent	Howmedica Corp.
K981526	ACE ALVEOLAR DISTRACTOR	Nov 06, 1998	Substantially Equivalent	Ace Surgical Supply Co., Inc.
K982139	BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM	Sep 15, 1998	Substantially Equivalent	Bionx Implants, Inc.
K981890	SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES	Aug 18, 1998	Substantially Equivalent	Synthes (Usa)
K980983	THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY	Jun 09, 1998	Substantially Equivalent	Biomedics
K980927	LACTOSORB PANELS AND FASTENERS	Jun 05, 1998	Substantially Equivalent	Biomet, Inc.
K981070	20-HOLE ADAPTATION PLATE	May 20, 1998	Substantially Equivalent	Biomet, Inc.
K980512	LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW	May 11, 1998	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K973924	FRIOS BONESHIELD	May 07, 1998	Substantially Equivalent	Friatec AG
K974555	SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS)	Mar 03, 1998	Substantially Equivalent	Synthes (Usa)
K974554	SYNTHES RESORBABLE FIXATION SYSTEM	Feb 24, 1998	Substantially Equivalent	Synthes (Usa)
K973484	CHIN DISTRACTOR	Dec 02, 1997	Substantially Equivalent	Howmedica, Inc.
K973145	TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM	Nov 19, 1997	Substantially Equivalent	Sofamor Danek USA,Inc.
K972463	THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY	Sep 25, 1997	Substantially Equivalent	Biomedics
K972322	LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES	Aug 18, 1997	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K972166	GUERRERO - BELL DISTRACTOR	Aug 11, 1997	Substantially Equivalent	Howmedica Leibinger, Inc.
K972154	COHEN DISTRACTOR	Aug 11, 1997	Substantially Equivalent	Howmedica Leibinger, Inc.
K971987	SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR	Jun 24, 1997	Substantially Equivalent	Synthes (Usa)
K970841	IMTEC/TITANIUM MESH	Apr 30, 1997	Substantially Equivalent	Imtec Corp.
K970911	LEE PLATE	Apr 11, 1997	Substantially Equivalent	Howmedica Leibinger, Inc.
K970256	INTRAORAL MANDIBULAR DISTRACTION DEVICE	Mar 11, 1997	Substantially Equivalent	Medicon EG
K964649	VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE	Jan 24, 1997	Substantially Equivalent	Howmedica Leibinger, Inc.
K964328	SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE	Dec 13, 1996	Substantially Equivalent	Synthes (Usa)
K963394	OSTEOMED TRAM	Nov 14, 1996	Substantially Equivalent	Osteomed Corp.
K963740	LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS	Oct 28, 1996	Substantially Equivalent	Howmedica Leibinger, Inc.
K961976	THE BIOPLATE FIXATION SYSTEM	Aug 16, 1996	Substantially Equivalent	Biomedics
K961421	SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM	Jun 26, 1996	Substantially Equivalent	Synthes (Usa)
K960514	TMP MANDIBULAR COMPRESSION SYSTEM (MODIFICATION)	Apr 15, 1996	Substantially Equivalent	Anspach Fixation Systems
K960914	3I OSSEOUS FIXATION SYSTEM(S)	Apr 04, 1996	Substantially Equivalent	Implant Innovations, Inc.
K954385	SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM	Mar 08, 1996	Substantially Equivalent	Synthes (Usa)
K953806	SYNTHES (USA) MIDFACIAL SYSTEM	Mar 08, 1996	Substantially Equivalent	Synthes (Usa)
K953273	BIOPLATE RIGID FIXATION BONE PLATING SYSTEM	Sep 29, 1995	Substantially Equivalent	Biomedics
K953385	LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM	Sep 28, 1995	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K945500	WELLS JOHNSON FIXATION SYSTEM	Sep 21, 1995	Substantially Equivalent	Wells Johnson Co.
K953386	9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS	Sep 15, 1995	Substantially Equivalent	Implant Innovations, Inc.
K952812	3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM) BONE-MESH/PLATE & SCREWS	Aug 30, 1995	Substantially Equivalent	Implant Innovations, Inc.
K952811	3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: STAINLESS STEEL BONE-MESH/PLATE & SCREWS	Aug 30, 1995	Substantially Equivalent	Implant Innovations, Inc.
K951689	TITANIUM MANDIBULAT RECONSTRUCTION SYSTEM	Jul 27, 1995	Substantially Equivalent	Medicon EG
K951687	MESH TITANIUM IMPLANT SYSTEM	Jul 27, 1995	Substantially Equivalent	Medicon EG
K951691	CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEM	Jul 26, 1995	Substantially Equivalent	Medicon EG
K951690	TITANIUM MINIPLATE SYSTEM	Jul 26, 1995	Substantially Equivalent	Medicon EG
K951688	MICRO TITANIUM PLATE SYSTEM	Jul 26, 1995	Substantially Equivalent	Medicon EG
K950595	LUHR MANDIBULAR/SMALL FIXATION IMPLANTS	Jul 12, 1995	Substantially Equivalent	Howmedica Corp.
K952168	TITANIUM MANDIBULAR FRACTURE SYSTEM	Jun 22, 1995	Substantially Equivalent	Medicon, Inc.
K951392	MINIBONEPLATE SYSTEM	May 05, 1995	Substantially Equivalent	Ace Surgical Supply Co., Inc.
K950045	KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM	Mar 23, 1995	Substantially Equivalent	Karl Leibinger GmbH U. Co. KG
K943071	THE TITANIUM FIXATION SYSTEM	Jan 06, 1995	Substantially Equivalent	Biomedics
K944565	KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM)	Oct 18, 1994	Substantially Equivalent	KLS-Martin L.P.
K944561	MICRO OSTEOSYNTHESIS SYSTEM (1.0)	Oct 18, 1994	Substantially Equivalent	KLS-Martin L.P.
K944560	MAN SURG INSTR/ACCESS TO KLS-MARTIN MICRO OSTEO SYST	Oct 18, 1994	Substantially Equivalent	KLS-Martin L.P.
K943348	KLS CHIN PLATE SYSTEM	Oct 04, 1994	Substantially Equivalent	Patton, Boggs & Blow
K943347	KLS MINI OSTEOSYNTHESIS SYSTEM	Oct 04, 1994	Substantially Equivalent	Patton, Boggs & Blow
K943346	MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM	Oct 04, 1994	Substantially Equivalent	Patton, Boggs & Blow
K943345	MANUAL SURGICAL INST. AND ACC. TO KLS CHIN PLATE SYSTEM	Oct 04, 1994	Substantially Equivalent	Patton, Boggs & Blow
K931539	NORMED TITANIUM MINIPLATE SYSTEM	Jul 05, 1994	Substantially Equivalent	Normed Medizin-Technik GmbH
K923705	AESCULAP CRANIOFACIAL TITANIUM PLATES AND SCREWS	Feb 01, 1994	Substantially Equivalent	Aesculap, Inc.
K932492	IMPLANTOLOGY MODULE, MODEL 2175	Oct 05, 1993	Substantially Equivalent	Micro Surgical Instruments Corp.
K923419	TISMESH SYSTEM	Apr 08, 1993	Substantially Equivalent	Ti-Mesh, Inc.
K924138	OSTEOMED M3 SYSTEM (SBF SYSTEM)	Feb 17, 1993	Substantially Equivalent	Osteomed Corp.
K922741	LORENZ 1.0 MM SYSTEM	Dec 23, 1992	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K923802	TIMESH TITANIUM MINI-SOFTPLATE/SCREW	Oct 26, 1992	Substantially Equivalent	Ti-Mesh, Inc.
K921801	MODIFICATION TECHMEDICA MP (MINIPLATING) SYSTEM	Jul 15, 1992	Substantially Equivalent	Techmedica, Inc.
K913688	BUD MAXILLOFACIAL IMPLANT SYSTEM	May 05, 1992	Substantially Equivalent	Bud Industries, Inc.
K910038	LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM	Feb 20, 1991	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K901941	LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES	Sep 06, 1990	Substantially Equivalent	Howmedica Corp.
K901940	LUHR MICRO MESH	Sep 06, 1990	Substantially Equivalent	Howmedica Corp.
K901095	BI-PHASE SET, ORAL, MAXILLOFACIAL SURGERY	Apr 27, 1990	Substantially Equivalent	Grimm & Norton
K901094	HEAD FRAME KIT, ORAL MAXILLOFACIAL SURGERY	Apr 27, 1990	Substantially Equivalent	Grimm & Norton
K896404	TITAMED ANTWERP SYSTEM	Apr 16, 1990	Substantially Equivalent	Optik
K884523	MARTIN-CHAMPY TITAN SET	Dec 08, 1988	Substantially Equivalent	Buschmann Surgical Products
K873926	STORZ CONTOURED ANATOMICAL PLATING INSTRUMENT	Feb 19, 1988	Substantially Equivalent	Storz Instrument Co.
K870041	FLEXIBLE FASCICULATED BONE PLATE	Jul 17, 1987	Substantially Equivalent	The Deca Co.
K862532	DUMBACH TITANIUM MESH IMPLANT SYSTEM	Sep 05, 1986	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K862534	PAULUS TITANIUM MINI BONE PLATES & BONE SCREWS	Aug 07, 1986	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K862505	MANUAL SURG. INSTRU. FOR PAULUS TITANIUM SYSTEM	Aug 07, 1986	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K862533	MANUAL SURG. INSTRU. FOR STEINHAUSER BONE PLATE	Aug 01, 1986	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K862482	STEINHAUSER TITANIUM MINI BONE PLATES & SCREWS	Jul 25, 1986	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K862139	IMTECH FIXATION SYSTEMS	Jul 16, 1986	Substantially Equivalent	Imtech, Inc.
K855224	ACROMED NESTED BONE PLATE	Feb 04, 1986	Substantially Equivalent	Buckman Co., Inc.
K855030	CHAMPY BONE PLATES & BONE SCREWS	Jan 30, 1986	Substantially Equivalent	Advanced Biosearch Assn.
K854886	WUERZBURG TITANIUM MINI BONE PLATES & BONE SCREWS	Jan 21, 1986	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K840955	CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD	Jun 19, 1984	Substantially Equivalent	Synthes (Usa)