JEY · Plate, Bone
Dental · 21 CFR 872.4760 · Class 2
Overview
| Product Code | JEY |
|---|---|
| Device Name | Plate, Bone |
| Regulation | 21 CFR 872.4760 |
| Device Class | Class 2 |
| Review Panel | Dental |
| Implant | Yes |
Identification
A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.
Classification Rationale
Class II.
Cleared Devices (292)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252246 | Leforte MMF System | Jeil Medical Corporation | Apr 2, 2026 | SESE |
| K253373 | Southern Craniomaxillofacial (CMF) System | Southern Medical (Pty) , Ltd. | Dec 19, 2025 | SESE |
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | Inion OY | Nov 7, 2025 | SESE |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | KLS-Martin L.P. | Aug 16, 2024 | SESE |
| K240651 | MRI Universal | Stryker Leibinger GmbH & Co KG | Jul 12, 2024 | SESE |
| K233874 | tmCMF Solution | Techmah Cmf | Jul 11, 2024 | SESE |
| K232889 | METICULY Patient-specific titanium maxillofacial mesh implant | Meticuly Co., Ltd. | Apr 30, 2024 | SESE |
| K232350 | Stryker Facial iD System | Stryker Craniomaxillofacial | Jan 13, 2024 | SESE |
| K230398 | MedCAD® AccuPlate® 3DTi Patient-Specific Plating System | Medcad | Sep 26, 2023 | SESE |
| K230733 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | Aug 5, 2023 | SESE |
| K222650 | Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate | Stryker Craniomaxillofacial (Cmf) | Dec 9, 2022 | SESE |
| K220360 | Tandry CMF Plate System | Microware Precision Co., Ltd. | Nov 10, 2022 | SESE |
| K221855 | Universal CMF System | Stryker Leibinger GmbH & Co KG | Nov 9, 2022 | SESE |
| K210731 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | Jul 18, 2022 | SESE |
| K213777 | Stryker Resorbable Fixation System | Stryker Leibinger Micro Implants | Feb 4, 2022 | SESE |
| K202969 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | Aug 5, 2021 | SESE |
| K202918 | OsteoSync Ti Dental Mesh | Sites Medical, LLC | Jul 14, 2021 | SESE |
| K203282 | TECHFIT Patient-Specific Maxillofacial System | Industrias Medicas Sampedro S.A.S | May 19, 2021 | SESE |
| K193280 | MedCAD® AccuPlate® Patient-Specific Plate | Medcad | Feb 12, 2021 | SESE |
| K201944 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) | Synthes (USA) Products, LLC | Sep 10, 2020 | SESE |
| K182759 | BoniPlus Dental G-Mesh System | Montjade Engineering Co., Ltd. | Jul 29, 2020 | SESE |
| K192747 | Yxoss CBR® | Reoss GmbH | Jun 17, 2020 | SESE |
| K191997 | FAICO CMF System | Faico Medical, LLC | Apr 22, 2020 | SESE |
| K193143 | Stryker Facial iD Plating System | Stryker | Mar 26, 2020 | SESE |
| K193136 | Stryker Customized Mandible Recon Plate Kit | Stryker | Mar 26, 2020 | SESE |
| K192655 | Depuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | Dec 30, 2019 | SESE |
| K182758 | MCI - CMF System | Mci Medical Concept Innovation, Inc. | Dec 5, 2019 | SESE |
| K191028 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | Nov 22, 2019 | SESE |
| K190696 | Stryker Surgeon iD Mandible Recon Plate | Stryker | Jun 28, 2019 | SESE |
| K182609 | Delphos Implants Rigid Fixation System | Delphos Implants - Ind.Com. Importacao E Exportacao DE | Mar 29, 2019 | SESE |
| K182305 | Stryker Facial iD Plating System | Stryker | Jan 7, 2019 | SESE |
| K180204 | CranioMaxillofacial Fixation (CMF) System - CMF Visionare | Visionare, LLC | Dec 28, 2018 | SESE |
| K180249 | OmniPore DUROMAX Surgical Implants | Matrix Surgical Holdings, LLC/Matrix Surgical USA | Oct 11, 2018 | SESE |
| K180962 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | Aug 13, 2018 | SESE |
| K173039 | TruMatch CMF Titanium 3D Printed Implant | Materialise NV | Jul 10, 2018 | SESE |
| K170697 | GBR system | Surgident | May 24, 2018 | SESE |
| K172354 | OssBuilder System | Osstem Implant Co., Ltd. | Mar 26, 2018 | SESE |
| K173320 | KLS Martin L1 MMF System | KLS Martin L.P. | Feb 23, 2018 | SESE |
| K163579 | KLS Martin Individual Patient Solutions | KLS Martin L.P. | Nov 21, 2017 | SESE |
| K170773 | Stryker Universal Mesh | Stryker | Nov 8, 2017 | SESE |
| K172572 | Stryker Upper-Face AXS screws and Mid-Face AXS screws | Stryker | Oct 31, 2017 | SESE |
| K170272 | TruMatch CMF Titanium 3D Printed Implant System | Materialise NV | Aug 8, 2017 | SESE |
| K171364 | MP LeFort I Plates | Stryker | Jul 24, 2017 | SESE |
| K160363 | OPTIMUS CMF SYSTEM | Osteonic Co., Ltd. | Oct 20, 2016 | SESE |
| K152326 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | Dec 10, 2015 | SESE |
| K150965 | LeForte System II | Jeil Medical Corporation | Sep 17, 2015 | SESE |
| K143730 | GBR System | Jeil Medical Corporation | Jun 10, 2015 | SESE |
| K142568 | Stryker MEDPOR TITAN 3D Orbital Floor Implant | Stryker | May 5, 2015 | SESE |
| K143338 | Argulated Locking Plates | Osteomed LP | Apr 1, 2015 | SESE |
| K143336 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | Apr 1, 2015 | SESE |
| K140037 | OPTIMUS CMF SYSTEM | Osteonic Co., Ltd. | Jan 20, 2015 | SESE |
| K141764 | TRISTAR BONE GRAFT FIXATION SYSTEM | Impladent , Ltd. | Dec 18, 2014 | SESE |
| K140978 | OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM | Osteomed | Dec 18, 2014 | SESE |
| K141165 | MATRIXWAVE MMF SYSTEM | Synthes (USA) Products, LLC | Oct 17, 2014 | SESE |
| K133461 | STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM | Stryker | Aug 1, 2014 | SESE |
| K133304 | RXG DISTRACTION SYSTEM | KLS-Martin L.P. | May 15, 2014 | SESE |
| K121235 | LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM | Stryker | Jan 9, 2014 | SESE |
| K132519 | STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT | Stryker | Dec 6, 2013 | SESE |
| K132600 | FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING | Biomet Microfixation | Oct 2, 2013 | SESE |
| K131289 | I-GEN | Megagen Implant Co., Ltd. | Sep 25, 2013 | SESE |
| K130840 | SMARTBUILDER SYSTEM (SB1) | Osstem Implant Co., Ltd. | Sep 18, 2013 | SESE |
| K131674 | PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING | Biomet Microfixation | Aug 8, 2013 | SESE |
| K123786 | STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM | Stryker | Apr 9, 2013 | SESE |
| K122647 | SYNTHES PATIENT SPECIFIC PLATE | Synthes, Inc. | Feb 28, 2013 | SESE |
| K122890 | INION CPS ORBITAL PLATES | Inion OY | Jan 29, 2013 | SESE |
| K113567 | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM | Synthes, Inc. | Nov 19, 2012 | SESE |
| K122313 | STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM | Stryker | Oct 31, 2012 | SESE |
| K120951 | SMARTBUILDER SYSTEM | Osstem Implant Co., Ltd. | Oct 3, 2012 | SESE |
| K121589 | BIOMET MICROFIXATION FACIAL PLATING SYSTEM | Biomet Microfixation | Sep 21, 2012 | SESE |
| K121574 | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM | Synthes, Inc. | Jun 29, 2012 | SESE |
| K113512 | BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM | Biomet Microfixation | Jun 29, 2012 | SESE |
| K120271 | ARTISAN SPACE MAINTENANCE SYSTEM | Medtronic Sofamor Danek USA, Inc. | May 30, 2012 | SESE |
| K112457 | LEFORTE SYSTEM BONE PLATE & SCREW | Arkin Consulting Group | May 18, 2012 | SESE |
| K112064 | RESORB X-G | KLS-Martin L.P. | Mar 23, 2012 | SESE |
| K111761 | NEO TITANIUM MESH, CTI-MEM | Neobiotech Co., Ltd. | Jan 10, 2012 | SESE |
| K113251 | SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES | Synthes, Inc. | Dec 21, 2011 | SESE |
| K110926 | BONE PLATE; BONE SCREW | Biomaterials Korea, Inc. | Dec 8, 2011 | SESE |
| K110259 | ARCHITEX SPACE MAINTENANCE SYSTEM | Medtronic Sofamor Danek USA, Inc. | Apr 13, 2011 | SESE |
| K103136 | SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE | Materialise NV | Mar 18, 2011 | SESE |
| K103778 | LEFORTE NEURO SYSTEM BONE PLATE | Jeil Medical Corporation | Jan 26, 2011 | SESE |
| K102656 | SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM | Synthes (Usa) | Dec 20, 2010 | SESE |
| K102641 | MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE | Neoortho Produtos Ortopedicos S/A | Dec 20, 2010 | SESE |
| K100779 | SUSTAIN SPACE MAINTENANCE SYSTEM | Medtronic Sofamor Danek USA, Inc. | Dec 13, 2010 | SESE |
| K091807 | MEDPOR FIXATION SYSTEM | Porex Surgical, Inc. | Jun 28, 2010 | SESE |
| K091812 | FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS | Frontier Devices, Inc. | May 7, 2010 | SESE |
| K092743 | THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM | Stryker Craniomaxillofacial | Jan 15, 2010 | SESE |
| K091233 | SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES | Synthes (Usa) | Dec 11, 2009 | SESE |
| K091679 | LEFORTE SYSTEM BONE PLATE | Jeil Medical Corporation | Oct 2, 2009 | SESE |
| K091144 | SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES | Synthes (Usa) | Aug 25, 2009 | SESE |
| K083388 | SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM | Synthes (Usa) | Mar 12, 2009 | SESE |
| K082335 | SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM | Synthes (Usa) | Nov 10, 2008 | SESE |
| K073307 | MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM | Bio-Technology USA, Inc. | Oct 29, 2008 | SESE |
| K082757 | MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM | Bioplate, Inc. | Oct 1, 2008 | SESE |
| K080862 | SONICWELD RX (RESORB-X) | KLS-Martin L.P. | Jul 21, 2008 | SESE |
| K080694 | OSTEOMED MODULAR LOCKING FIXATION SYSTEM | Osteomed LP | May 15, 2008 | SESE |
| K081067 | FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) | Biomet Microfixation, Inc. | May 9, 2008 | SESE |
| K080331 | SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM | Synthes (Usa) | Apr 30, 2008 | SESE |
| K072528 | ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES | Prosurg, Inc. | Dec 28, 2007 | SESE |
| K072463 | SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM | Satyrne Medical | Nov 29, 2007 | SESE |
| K071612 | MODUS TRILOCK 2.0/2.3/2.5 | Medartis AG | Sep 11, 2007 | SESE |
| K062436 | SIS SINUS IMPLANT STABILIZER | Mondeal Medical Systems GmbH | Jul 30, 2007 | SESE |
| K070737 | XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES | Prosurg, Inc. | Jul 25, 2007 | SESE |
| K063790 | THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM | Synthes (Usa) | Apr 16, 2007 | SESE |
| K061881 | OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM | Takiron Co., Ltd. | Mar 14, 2007 | SESE |
| K062789 | SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM | Synthes (Usa) | Feb 27, 2007 | SESE |
| K063052 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES | Walter Lorenz Surgical, Inc. | Jan 12, 2007 | SESE |
| K061507 | SONICWELD RX ENDOBROW FIXATION | KLS-Martin L.P. | Sep 21, 2006 | SESE |
| K060177 | KLS MARTIN RIGID FIXATION - STERILE | KLS Martin L.P. | Apr 18, 2006 | SESE |
| K060492 | AESCULAP CRANIOFACIAL PLATE AND SCREW | Aesculap, Inc. | Apr 7, 2006 | SESE |
| K052444 | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM | Inion , Ltd. | Sep 20, 2005 | SESE |
| K051236 | RESORB-X SF | KLS-Martin L.P. | Aug 22, 2005 | SESE |
| K051845 | THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM | Bioplate, Inc. | Jul 27, 2005 | SESE |
| K051293 | CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM | Ceremed , Inc. | Jun 14, 2005 | SESE |
| K051341 | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059 | Inion , Ltd. | May 27, 2005 | SESE |
| K050669 | JEIL BONE FIXATION SYSTEM | Jeil Medical Corporation | May 26, 2005 | SESE |
| K050608 | SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM | Synthes (Usa) | May 18, 2005 | SESE |
| K050934 | MODUS TITANIUM OSTEOSYNTHESIS SYSTEM | Medartis, Inc. | May 5, 2005 | SESE |
| K050204 | SYNTHES RAPID RESORBABLE TACK SYSTEM | Synthes (Usa) | Mar 4, 2005 | SESE |
| K043297 | MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM | Medicon EG | Feb 23, 2005 | SESE |
| K042987 | MODIFICATION TO SYNTHES CRANIAL PLATES | Synthes (Usa) | Nov 23, 2004 | SESE |
| K042365 | SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM | Synthes (Usa) | Nov 18, 2004 | SESE |
| K042517 | BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS | Linvatec Biomaterials, Ltd. | Oct 8, 2004 | SESE |
| K040650 | BONAMATES SERIES | Biotech One, Inc. | Jun 3, 2004 | SESE |
| K030425 | LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER | Walter Lorenz Surgical, Inc. | May 14, 2004 | SESE |
| K033092 | THE GNATHOMETER | Ortho Gnathics, LLC | Apr 21, 2004 | SESE |
| K030989 | OSTEOSORB TACK FIXATION SYSTEM | Noviace Corporation | Apr 1, 2004 | SESE |
| K040272 | SYNTHES (USA) CRANIOFACIAL PLATES | Synthes (Usa) | Feb 23, 2004 | SESE |
| K032520 | ORTRAUTEK TRAUMA SYSTEM | Tekka | Nov 12, 2003 | SESE |
| K033194 | INION CPS BABY 1.5 BIOABSORBABLE SYSTEM | Inion , Ltd. | Oct 30, 2003 | SESE |
| K031989 | ORTRAUTEK ORTHOGNATHIC SYSTEM | Tekka | Oct 28, 2003 | SESE |
| K033121 | 1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES | Synthes (Usa) | Oct 20, 2003 | SESE |
| K033160 | SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES | Synthes (Usa) | Oct 9, 2003 | SESE |
| K031659 | UNIVERSAL NEURO SYSTEM | Stryker Instruments | Sep 10, 2003 | SESE |
| K031761 | SYNTHES (USA) NEW/STERIAL ORBITAL PLATES | Synthes (Usa) | Sep 3, 2003 | SESE |
| K030448 | OSTEOMED 2.0 LOCKING PLATES AND SCREWS | Osteomed LP | May 9, 2003 | SESE |
| K031028 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Bioplate, Inc. | Apr 28, 2003 | SESE |
| K030806 | BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Bioplate, Inc. | Apr 8, 2003 | SESE |
| K030069 | SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM | Synthes (Usa) | Apr 8, 2003 | SESE |
| K022035 | OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB | Osteomedics, Inc. | Jan 17, 2003 | SESE |
| K022844 | SYNTHES RESORBABLE CONTOURABLE MESH | Synthes (Usa) | Jan 7, 2003 | SESE |
| K022185 | UNIVERSAL CMF SYSTEM | Stryker Instruments | Dec 17, 2002 | SESE |
| K023810 | MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Bioplate, Inc. | Dec 4, 2002 | SESE |
| K023665 | MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Bioplate, Inc. | Nov 22, 2002 | SESE |
| K022012 | SYNTHES LOW PROFILE NEURO SYSTEM | Synthes (Usa) | Nov 1, 2002 | SESE |
| K023488 | OSSTAPLE, CRANIOFACIAL | Biomedical Enterprises, Inc. | Oct 31, 2002 | SESE |
| K023486 | OSSTAPLE, MAXILLOFACIAL | Biomedical Enterprises, Inc. | Oct 31, 2002 | SESE |
| K022890 | MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Bioplate, Inc. | Sep 6, 2002 | SESE |
| K021928 | SYNTHES (USA) RESORBABLE FIXATION SYSTEM | Synthes (Usa) | Sep 6, 2002 | SESE |
| K022005 | SYNTHES MIDFACE DISTRACTOR | Synthes (Usa) | Sep 3, 2002 | SESE |
| K021642 | SYNTHES CRANIOFACIAL PLATES | Synthes (Usa) | Aug 14, 2002 | SESE |
| K021618 | OSA RIGID INTERNAL FIXATION SYSTEM | Osteomed Corp. | Aug 8, 2002 | SESE |
| K021511 | CYTOFLEX MESH | Unicare Biomedical, Inc. | Aug 6, 2002 | SESE |
| K021342 | NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR | Osteomedics, Inc. | Aug 1, 2002 | SESE |
| K021341 | NORMED BONE TRANSPORT DISTRACTION DEVICE | Osteomedics, Inc. | Aug 1, 2002 | SESE |
| K022033 | STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM | Bioplate, Inc. | Jul 19, 2002 | SESE |
| K021684 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Bioplate, Inc. | Jun 26, 2002 | SESE |
| K021382 | SYNTHES (USA) AUTOMATED TACK DRIVER | Synthes (Usa) | May 16, 2002 | SESE |
| K020505 | SYNTHES TRANSLATING MAXILLARY DISTRACTOR | Synthes (Usa) | Apr 23, 2002 | SESE |
| K013672 | BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM | Azary Technologies, LLC | Apr 8, 2002 | SESE |
| K011590 | RESORB-X RESORBABLE PLATING SYSTEM | KLS-Martin L.P. | Mar 20, 2002 | SESE |
| K014263 | NEWGEN/UNIVERSAL MANDIBULAR SYSTEM | Stryker Instruments | Mar 8, 2002 | SESE |
| K011569 | BIOSORBFX O/M 2.0/2/4 SYSTEM | Bionx Implants, Inc. | Feb 22, 2002 | SESE |
| K020087 | SYNTHES CRANIAL PLATES | Synthes (Usa) | Feb 20, 2002 | SESE |
| K013055 | THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM | Bioplate, Inc. | Dec 7, 2001 | SESE |
| K012910 | THE BIOPLATE MANDIBLE FIXATION SYSTEM | Bioplate, Inc. | Nov 20, 2001 | SESE |
| K013039 | INION CPS 2.0 ORTHOGNATHIC PLATE | Inion , Ltd. | Oct 5, 2001 | SESE |
| K012413 | MACROPORE FX, PS, NS, LP | Macropore Biosurgery, Inc. | Sep 18, 2001 | SESE |
| K011698 | STRAUMANN GBR SYSTEM | Institut Straumann AG | Aug 23, 2001 | SESE |
| K010118 | NORMED MANDIBULAR FIXATION SYSTEM | Osteomedics, Inc. | Aug 14, 2001 | SESE |
| K003281 | LACTOSORB RAPIDFLAP | Biomet, Inc. | Aug 7, 2001 | SESE |
| K002207 | MACROPOREPX PEDIATRIC SYSTEM | Macropore Biosurgery, Inc. | Jul 11, 2001 | SESE |
| K011380 | MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM | Bioplate, Inc. | May 14, 2001 | SESE |
| K010499 | SYNTHES (USA) MIDFACE DISTRACTOR | Synthes (Usa) | May 3, 2001 | SESE |
| K010351 | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM | Inion , Ltd. | Mar 15, 2001 | SESE |
| K010687 | BIOSORBFX AND BIOSORBPDX MESH | Bionx Implants, Inc. | Mar 14, 2001 | SESE |
| K010352 | CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM | Inion , Ltd. | Mar 14, 2001 | SESE |
| K003786 | SMF RESORBABLE MESHES AND SHEETS | Synthes (Usa) | Feb 27, 2001 | SESE |
| K003549 | CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS | Codman & Shurtleff, Inc. | Feb 15, 2001 | SESE |
| K002083 | LORENZ RESORBABLE DISTRACTOR SYSTEM | Walter Lorenz Surgical, Inc. | Feb 12, 2001 | SESE |
| K003757 | THERMOFX MESH | Bionx Implants, Ltd. | Feb 7, 2001 | SESE |
| K002426 | THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY | Bioplate, Inc. | Jan 26, 2001 | SESE |
| K994060 | THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE | Bioplate, Inc. | Jan 24, 2001 | SESE |
| K003883 | MOLINA ORBITAL MALAR DISTRACTOR | KLS-Martin L.P. | Jan 23, 2001 | SESE |
| K003393 | MAXILLARY DISTRACTOR | Synthes (Usa) | Jan 17, 2001 | SESE |
| K000560 | SYNTHES (USA) RESORBABLE TACK SYSTEM | Synthes (Usa) | Jan 9, 2001 | SESE |
| K003756 | BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES | Bionx Implants, Inc. | Jan 3, 2001 | SESE |
| K003660 | LEIBINGER NEURO CLIP SYSTEM | Stryker Instruments | Dec 12, 2000 | SESE |
| K000594 | LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE | Stryker Leibinger | Dec 8, 2000 | SESE |
| K002798 | CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS | Codman & Shurtleff, Inc. | Dec 6, 2000 | SESE |
| K002619 | NEWGEN SYSTEM | Stryker Instruments | Nov 16, 2000 | SESE |
| K000696 | MACROPOREMX MANDIBULAR FIXATION SYSTEM | Macropore Biosurgery, Inc. | Oct 19, 2000 | SESE |
| K002879 | MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM | Bioplate, Inc. | Oct 5, 2000 | SESE |
| K992905 | CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM | Codman & Shurtleff, Inc. | Aug 1, 2000 | SESE |
| K001530 | THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM | Bioplate, Inc. | Jul 21, 2000 | SESE |
| K001219 | MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM | Biomedical Ent., Inc. | Jun 21, 2000 | SESE |
| K000836 | BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM | Bionx Implants, Inc. | Jun 8, 2000 | SESE |
| K001238 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM | Walter Lorenz Surgical, Inc. | May 3, 2000 | SESE |
| K994154 | MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES | KLS-Martin L.P. | Feb 15, 2000 | SESE |
| K993862 | MODUS SAGITTAL SPLIT PLATE | The Straumann Co. | Dec 29, 1999 | SESE |
| K992683 | MODUS 2.5 MANDIBULAR TRAUMA SET | Medartis AG | Nov 24, 1999 | SESE |
Top Applicants
- Synthes (Usa) — 38 clearances
- Bioplate, Inc. — 16 clearances
- Walter Lorenz Surgical, Inc. — 15 clearances
- KLS-Martin L.P. — 15 clearances
- Stryker — 13 clearances
