FDA 510(k) Applications for Medical Device Product Code "JEY"
(Plate, Bone)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K981526 | ACE SURGICAL SUPPLY CO., INC. | ACE ALVEOLAR DISTRACTOR | 11/06/1998 |
| K990140 | ACE SURGICAL SUPPLY CO., INC. | NORMED BONE TRANSPORT | 03/25/1999 |
| K060492 | AESCULAP, INC. | AESCULAP CRANIOFACIAL PLATE AND SCREW | 04/07/2006 |
| K960514 | ANSPACH FIXATION SYSTEMS | TMP MANDIBULAR COMPRESSION SYSTEM (MODIFICATION) | 04/15/1996 |
| K112457 | ARKIN CONSULTING GROUP | LEFORTE SYSTEM BONE PLATE & SCREW | 05/18/2012 |
| K013672 | AZARY TECHNOLOGIES LLC. | BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM | 04/08/2002 |
| K073307 | BIO-TECHNOLOGY USA, INC. | MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM | 10/29/2008 |
| K110926 | BIOMATERIALS KOREA INC. | BONE PLATE; BONE SCREW | 12/08/2011 |
| K001219 | BIOMEDICAL ENT., INC. | MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM | 06/21/2000 |
| K023488 | BIOMEDICAL ENTERPRISES, INC | OSSTAPLE, CRANIOFACIAL | 10/31/2002 |
| K023486 | BIOMEDICAL ENTERPRISES, INC | OSSTAPLE, MAXILLOFACIAL | 10/31/2002 |
| K961976 | BIOMEDICS | THE BIOPLATE FIXATION SYSTEM | 08/16/1996 |
| K972463 | BIOMEDICS | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | 09/25/1997 |
| K980983 | BIOMEDICS | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | 06/09/1998 |
| K992330 | BIOMEDICS | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | 11/23/1999 |
| K121589 | BIOMET MICROFIXATION | BIOMET MICROFIXATION FACIAL PLATING SYSTEM | 09/21/2012 |
| K113512 | BIOMET MICROFIXATION | BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM | 06/29/2012 |
| K143336 | BIOMET MICROFIXATION | Biomet Microfixation OmniMax MMF System | 04/01/2015 |
| K152326 | BIOMET MICROFIXATION | Biomet Microfixation OmniMax MMF System | 12/10/2015 |
| K202969 | Biomet Microfixation | Biomet Microfixation OmniMax MMF System | 08/05/2021 |
| K132600 | BIOMET MICROFIXATION | FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING | 10/02/2013 |
| K131674 | BIOMET MICROFIXATION | PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING | 08/08/2013 |
| K081067 | BIOMET MICROFIXATION, INC. | FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) | 05/09/2008 |
| K981070 | BIOMET, INC. | 20-HOLE ADAPTATION PLATE | 05/20/1998 |
| K980927 | BIOMET, INC. | LACTOSORB PANELS AND FASTENERS | 06/05/1998 |
| K003281 | BIOMET, INC. | LACTOSORB RAPIDFLAP | 08/07/2001 |
| K992158 | BIOMET, INC. | LACTOSORB SHEETS | 08/20/1999 |
| K982139 | BIONX IMPLANTS, INC. | BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM | 09/15/1998 |
| K982721 | BIONX IMPLANTS, INC. | BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM | 02/17/1999 |
| K010687 | BIONX IMPLANTS, INC. | BIOSORBFX AND BIOSORBPDX MESH | 03/14/2001 |
| K011569 | BIONX IMPLANTS, INC. | BIOSORBFX O/M 2.0/2/4 SYSTEM | 02/22/2002 |
| K003756 | BIONX IMPLANTS, INC. | BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES | 01/03/2001 |
| K000836 | BIONX IMPLANTS, INC. | BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM | 06/08/2000 |
| K003757 | BIONX IMPLANTS, LTD. | THERMOFX MESH | 02/07/2001 |
| K030806 | BIOPLATE, INC. | BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | 04/08/2003 |
| K002879 | BIOPLATE, INC. | MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM | 10/05/2000 |
| K023665 | BIOPLATE, INC. | MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | 11/22/2002 |
| K023810 | BIOPLATE, INC. | MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | 12/04/2002 |
| K011380 | BIOPLATE, INC. | MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM | 05/14/2001 |
| K022890 | BIOPLATE, INC. | MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | 09/06/2002 |
| K082757 | BIOPLATE, INC. | MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM | 10/01/2008 |
| K022033 | BIOPLATE, INC. | STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM | 07/19/2002 |
| K001530 | BIOPLATE, INC. | THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM | 07/21/2000 |
| K013055 | BIOPLATE, INC. | THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM | 12/07/2001 |
| K012910 | BIOPLATE, INC. | THE BIOPLATE MANDIBLE FIXATION SYSTEM | 11/20/2001 |
| K002426 | BIOPLATE, INC. | THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY | 01/26/2001 |
| K994060 | BIOPLATE, INC. | THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE | 01/24/2001 |
| K051845 | BIOPLATE, INC. | THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM | 07/27/2005 |
| K031028 | BIOPLATE, INC. | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | 04/28/2003 |
| K021684 | BIOPLATE, INC. | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | 06/26/2002 |
| K040650 | BIOTECH ONE, INC. | BONAMATES SERIES | 06/03/2004 |
| K051293 | CEREMED, INC. | CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM | 06/14/2005 |
| K992905 | Codman & Shurtleff, Inc. | CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM | 08/01/2000 |
| K002798 | Codman & Shurtleff, Inc. | CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS | 12/06/2000 |
| K003549 | Codman & Shurtleff, Inc. | CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS | 02/15/2001 |
| K182609 | Delphos Implants - Ind.Com. Importacao e Exportacao de | Delphos Implants Rigid Fixation System | 03/29/2019 |
| K990920 | DOCTOR'S RESEARCH GROUP, INC. | DRG TITANIUM BONE PLATE | 06/10/1999 |
| K191997 | FAICO Medical LLC | FAICO CMF System | 04/22/2020 |
| K973924 | FRIATEC AG | FRIOS BONESHIELD | 05/07/1998 |
| K091812 | FRONTIER DEVICES, INC. | FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS | 05/07/2010 |
| K983535 | HANS HERMANN GMBH | THE TITANIUM MINIPLATING SYSTEM, THE TITANIUM MICROPLATING SYSTEM, THE TITANIUM MEDIUMPLATING SYSTEM, MODEL #'S H12-1010 | 12/29/1998 |
| K983528 | HOWMEDICA CORP. | MICRO DYNAMIC MESH | 12/23/1998 |
| K972154 | HOWMEDICA LEIBINGER, INC. | COHEN DISTRACTOR | 08/11/1997 |
| K972166 | HOWMEDICA LEIBINGER, INC. | GUERRERO - BELL DISTRACTOR | 08/11/1997 |
| K970911 | HOWMEDICA LEIBINGER, INC. | LEE PLATE | 04/11/1997 |
| K963740 | HOWMEDICA LEIBINGER, INC. | LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS | 10/28/1996 |
| K964649 | HOWMEDICA LEIBINGER, INC. | VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE | 01/24/1997 |
| K983885 | HOWMEDICA, INC. | BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES | 01/29/1999 |
| K973484 | HOWMEDICA, INC. | CHIN DISTRACTOR | 12/02/1997 |
| K141764 | IMPLADENT, LTD. | TRISTAR BONE GRAFT FIXATION SYSTEM | 12/18/2014 |
| K960914 | IMPLANT INNOVATIONS, INC. | 3I OSSEOUS FIXATION SYSTEM(S) | 04/04/1996 |
| K970841 | IMTEC CORP. | IMTEC/TITANIUM MESH | 04/30/1997 |
| K203282 | Industrias Medicas Sampedro S.A.S. | TECHFIT Patient-Specific Maxillofacial System | 05/19/2021 |
| K010352 | INION LTD. | CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM | 03/14/2001 |
| K013039 | INION LTD. | INION CPS 2.0 ORTHOGNATHIC PLATE | 10/05/2001 |
| K010351 | INION LTD. | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM | 03/15/2001 |
| K052444 | INION LTD. | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM | 09/20/2005 |
| K051341 | INION LTD. | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059 | 05/27/2005 |
| K033194 | INION LTD. | INION CPS BABY 1.5 BIOABSORBABLE SYSTEM | 10/30/2003 |
| K122890 | INION OY | INION CPS ORBITAL PLATES | 01/29/2013 |
| K011698 | INSTITUT STRAUMANN AG | STRAUMANN GBR SYSTEM | 08/23/2001 |
| K143730 | JEIL MEDICAL CORPORATION | GBR System | 06/10/2015 |
| K050669 | JEIL MEDICAL CORPORATION | JEIL BONE FIXATION SYSTEM | 05/26/2005 |
| K103778 | JEIL MEDICAL CORPORATION | LEFORTE NEURO SYSTEM BONE PLATE | 01/26/2011 |
| K091679 | JEIL MEDICAL CORPORATION | LEFORTE SYSTEM BONE PLATE | 10/02/2009 |
| K150965 | Jeil Medical Corporation | LeForte System II | 09/17/2015 |
| K060177 | KLS MARTIN L.P. | KLS MARTIN RIGID FIXATION - STERILE | 04/18/2006 |
| K163579 | KLS Martin LP | KLS Martin Individual Patient Solutions | 11/21/2017 |
| K173320 | KLS Martin LP | KLS Martin L1 MMF System | 02/23/2018 |
| K180962 | KLS-Martin L.P. | KLS Martin Individual Patient Solutions | 08/13/2018 |
| K191028 | KLS-Martin L.P. | KLS Martin Individual Patient Solutions | 11/22/2019 |
| K210731 | KLS-Martin L.P. | KLS Martin Individual Patient Solutions | 07/18/2022 |
| K994154 | KLS-MARTIN L.P. | MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES | 02/15/2000 |
| K003883 | KLS-MARTIN L.P. | MOLINA ORBITAL MALAR DISTRACTOR | 01/23/2001 |
| K112064 | KLS-MARTIN L.P. | RESORB X-G | 03/23/2012 |
| K011590 | KLS-MARTIN L.P. | RESORB-X RESORBABLE PLATING SYSTEM | 03/20/2002 |
| K051236 | KLS-MARTIN L.P. | RESORB-X SF | 08/22/2005 |
| K133304 | KLS-MARTIN L.P. | RXG DISTRACTION SYSTEM | 05/15/2014 |
| K080862 | KLS-MARTIN L.P. | SONICWELD RX (RESORB-X) | 07/21/2008 |
| K061507 | KLS-MARTIN L.P. | SONICWELD RX ENDOBROW FIXATION | 09/21/2006 |
| K042517 | LINVATEC BIOMATERIALS, LTD. | BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS | 10/08/2004 |
| K012413 | MACROPORE BIOSURGERY, INC. | MACROPORE FX, PS, NS, LP | 09/18/2001 |
| K000696 | MACROPORE BIOSURGERY, INC. | MACROPOREMX MANDIBULAR FIXATION SYSTEM | 10/19/2000 |
| K002207 | MACROPORE BIOSURGERY, INC. | MACROPOREPX PEDIATRIC SYSTEM | 07/11/2001 |
| K103136 | MATERIALISE N.V. | SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE | 03/18/2011 |
| K173039 | Materialise NV | TruMatch CMF Titanium 3D Printed Implant | 07/10/2018 |
| K170272 | Materialise NV | TruMatch CMF Titanium 3D Printed Implant System | 08/08/2017 |
| K180249 | Matrix Surgical Holdings, LLC/Matrix Surgical USA | OmniPore DUROMAX Surgical Implants | 10/11/2018 |
| K182758 | MCI Medical Concept Innovation Inc. | MCI - CMF System | 12/05/2019 |
| K992682 | MEDARTIS AG | MODUS 2.5 MANDIBULAR RECONSTRUCTION SET | 11/24/1999 |
| K992683 | MEDARTIS AG | MODUS 2.5 MANDIBULAR TRAUMA SET | 11/24/1999 |
| K071612 | MEDARTIS AG | MODUS TRILOCK 2.0/2.3/2.5 | 09/11/2007 |
| K050934 | MEDARTIS, INC. | MODUS TITANIUM OSTEOSYNTHESIS SYSTEM | 05/05/2005 |
| K230398 | MedCAD | MedCAD« AccuPlate« 3DTi Patient-Specific Plating System | 09/26/2023 |
| K193280 | MedCAD | MedCAD« AccuPlate« Patient-Specific Plate | 02/12/2021 |
| K970256 | MEDICON, E.G. | INTRAORAL MANDIBULAR DISTRACTION DEVICE | 03/11/1997 |
| K043297 | MEDICON, E.G. | MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM | 02/23/2005 |
| K110259 | MEDTRONIC SOFAMOR DANEK USA, INC. | ARCHITEX SPACE MAINTENANCE SYSTEM | 04/13/2011 |
| K120271 | MEDTRONIC SOFAMOR DANEK USA, INC. | ARTISAN SPACE MAINTENANCE SYSTEM | 05/30/2012 |
| K100779 | MEDTRONIC SOFAMOR DANEK USA, INC. | SUSTAIN SPACE MAINTENANCE SYSTEM | 12/13/2010 |
| K131289 | MEGAGEN IMPLANT CO., LTD | I-GEN | 09/25/2013 |
| K220360 | Microware Precision Co., Ltd. | Tandry CMF Plate System | 11/10/2022 |
| K062436 | MONDEAL MEDICAL SYSTEMS GMBH | SIS SINUS IMPLANT STABILIZER | 07/30/2007 |
| K182759 | MontJade Engineering Co., Ltd. | BoniPlus Dental G-Mesh System | 07/29/2020 |
| K111761 | NEOBIOTECH CO., LTD. | NEO TITANIUM MESH, CTI-MEM | 01/10/2012 |
| K102641 | NEOORTHO PRODUTOS ORTOPEDICOS S/A | MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE | 12/20/2010 |
| K030989 | NOVIACE CORPORATION | OSTEOSORB TACK FIXATION SYSTEM | 04/01/2004 |
| K033092 | ORTHO GNATHICS LLC | THE GNATHOMETER | 04/21/2004 |
| K172354 | Osstem Implant Co., Ltd.. | OssBuilder System | 03/26/2018 |
| K120951 | OSSTEM IMPLANT CO.,LTD | SMARTBUILDER SYSTEM | 10/03/2012 |
| K130840 | OSSTEM IMPLANT CO.,LTD | SMARTBUILDER SYSTEM (SB1) | 09/18/2013 |
| K984230 | OSTEOGENICS BIOMEDICAL, INC. | OSTEO-MESH TM-300 | 02/04/1999 |
| K140978 | OSTEOMED | OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM | 12/18/2014 |
| K021618 | OSTEOMED CORP. | OSA RIGID INTERNAL FIXATION SYSTEM | 08/08/2002 |
| K963394 | OSTEOMED CORP. | OSTEOMED TRAM | 11/14/1996 |
| K143338 | OSTEOMED L.P. | Argulated Locking Plates | 04/01/2015 |
| K030448 | OSTEOMED L.P. | OSTEOMED 2.0 LOCKING PLATES AND SCREWS | 05/09/2003 |
| K080694 | OSTEOMED L.P. | OSTEOMED MODULAR LOCKING FIXATION SYSTEM | 05/15/2008 |
| K021342 | OSTEOMEDICS, INC. | NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR | 08/01/2002 |
| K021341 | OSTEOMEDICS, INC. | NORMED BONE TRANSPORT DISTRACTION DEVICE | 08/01/2002 |
| K010118 | OSTEOMEDICS, INC. | NORMED MANDIBULAR FIXATION SYSTEM | 08/14/2001 |
| K022035 | OSTEOMEDICS, INC. | OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB | 01/17/2003 |
| K160363 | OSTEONIC Co., Ltd. | OPTIMUS CMF SYSTEM | 10/20/2016 |
| K140037 | OSTEONIC CO., LTD. | OPTIMUS CMF SYSTEM | 01/20/2015 |
| K983360 | PACIFIC MATERIALS AND INTERFACES | MACROPORE PROTECTIVE SHEET | 03/19/1999 |
| K091807 | POREX SURGICAL, INC. | MEDPOR FIXATION SYSTEM | 06/28/2010 |
| K072528 | PROSURG, INC. | ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES | 12/28/2007 |
| K070737 | PROSURG, INC. | XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES | 07/25/2007 |
| K192747 | ReOss GmbH | Yxoss CBR« | 06/17/2020 |
| K072463 | SATYRNE MEDICAL | SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM | 11/29/2007 |
| K202918 | Sites Medical, LLC | OsteoSyncÖ Ti Dental Mesh | 07/14/2021 |
| K973145 | SOFAMOR DANEK USA,INC. | TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM | 11/19/1997 |
| K121235 | Stryker | LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM | 01/09/2014 |
| K171364 | Stryker | MP LeFort I Plates | 07/24/2017 |
| K132519 | Stryker | STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT | 12/06/2013 |
| K193136 | Stryker | Stryker Customized Mandible Recon Plate Kit | 03/26/2020 |
| K182305 | Stryker | Stryker Facial iD Plating System | 01/07/2019 |
| K193143 | Stryker | Stryker Facial iD Plating System | 03/26/2020 |
| K142568 | Stryker | Stryker MEDPOR TITAN 3D Orbital Floor Implant | 05/05/2015 |
| K190696 | Stryker | Stryker Surgeon iD Mandible Recon Plate | 06/28/2019 |
| K170773 | Stryker | Stryker Universal Mesh | 11/08/2017 |
| K123786 | Stryker | STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM | 04/09/2013 |
| K133461 | Stryker | STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM | 08/01/2014 |
| K122313 | Stryker | STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM | 10/31/2012 |
| K172572 | Stryker | Stryker Upper-Face AXS screws and Mid-Face AXS screws | 10/31/2017 |
| K092743 | STRYKER CRANIOMAXILLOFACIAL | THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM | 01/15/2010 |
| K222650 | Stryker Craniomaxillofacial (CMF) | Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate | 12/09/2022 |
| K003660 | STRYKER INSTRUMENTS | LEIBINGER NEURO CLIP SYSTEM | 12/12/2000 |
| K002619 | STRYKER INSTRUMENTS | NEWGEN SYSTEM | 11/16/2000 |
| K014263 | STRYKER INSTRUMENTS | NEWGEN/UNIVERSAL MANDIBULAR SYSTEM | 03/08/2002 |
| K022185 | STRYKER INSTRUMENTS | UNIVERSAL CMF SYSTEM | 12/17/2002 |
| K031659 | STRYKER INSTRUMENTS | UNIVERSAL NEURO SYSTEM | 09/10/2003 |
| K000594 | STRYKER LEIBINGER | LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE | 12/08/2000 |
| K230733 | Stryker Leibinger GmbH & Co. KG | Stryker Resorbable Fixation System | 08/05/2023 |
| K221855 | Stryker Leibinger GmbH & Co. KG | Universal CMF System | 11/09/2022 |
| K213777 | Stryker Leibinger Micro Implants | Stryker Resorbable Fixation System | 02/04/2022 |
| K170697 | SURGIDENT | GBR system | 05/24/2018 |
| K033121 | SYNTHES (USA) | 1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES | 10/20/2003 |
| K003393 | SYNTHES (USA) | MAXILLARY DISTRACTOR | 01/17/2001 |
| K042987 | SYNTHES (USA) | MODIFICATION TO SYNTHES CRANIAL PLATES | 11/23/2004 |
| K003786 | SYNTHES (USA) | SMF RESORBABLE MESHES AND SHEETS | 02/27/2001 |
| K971987 | SYNTHES (USA) | SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR | 06/24/1997 |
| K981890 | SYNTHES (USA) | SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES | 08/18/1998 |
| K021382 | SYNTHES (USA) | SYNTHES (USA) AUTOMATED TACK DRIVER | 05/16/2002 |
| K040272 | SYNTHES (USA) | SYNTHES (USA) CRANIOFACIAL PLATES | 02/23/2004 |
| K010499 | SYNTHES (USA) | SYNTHES (USA) MIDFACE DISTRACTOR | 05/03/2001 |
| K953806 | SYNTHES (USA) | SYNTHES (USA) MIDFACIAL SYSTEM | 03/08/1996 |
| K042365 | SYNTHES (USA) | SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM | 11/18/2004 |
| K031761 | SYNTHES (USA) | SYNTHES (USA) NEW/STERIAL ORBITAL PLATES | 09/03/2003 |
| K062789 | SYNTHES (USA) | SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM | 02/27/2007 |
| K021928 | SYNTHES (USA) | SYNTHES (USA) RESORBABLE FIXATION SYSTEM | 09/06/2002 |
| K000560 | SYNTHES (USA) | SYNTHES (USA) RESORBABLE TACK SYSTEM | 01/09/2001 |
| K964328 | SYNTHES (USA) | SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE | 12/13/1996 |
| K974555 | SYNTHES (USA) | SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS) | 03/03/1998 |
| K961421 | SYNTHES (USA) | SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM | 06/26/1996 |
| K050608 | SYNTHES (USA) | SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM | 05/18/2005 |
| K020087 | SYNTHES (USA) | SYNTHES CRANIAL PLATES | 02/20/2002 |
| K080331 | SYNTHES (USA) | SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM | 04/30/2008 |
| K021642 | SYNTHES (USA) | SYNTHES CRANIOFACIAL PLATES | 08/14/2002 |
| K102656 | SYNTHES (USA) | SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM | 12/20/2010 |
| K022012 | SYNTHES (USA) | SYNTHES LOW PROFILE NEURO SYSTEM | 11/01/2002 |
| K954385 | SYNTHES (USA) | SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM | 03/08/1996 |
| K082335 | SYNTHES (USA) | SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM | 11/10/2008 |
| K091144 | SYNTHES (USA) | SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES | 08/25/2009 |
| K091233 | SYNTHES (USA) | SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES | 12/11/2009 |
| K083388 | SYNTHES (USA) | SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM | 03/12/2009 |
| K022005 | SYNTHES (USA) | SYNTHES MIDFACE DISTRACTOR | 09/03/2002 |
| K030069 | SYNTHES (USA) | SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM | 04/08/2003 |
| K050204 | SYNTHES (USA) | SYNTHES RAPID RESORBABLE TACK SYSTEM | 03/04/2005 |
| K022844 | SYNTHES (USA) | SYNTHES RESORBABLE CONTOURABLE MESH | 01/07/2003 |
| K974554 | SYNTHES (USA) | SYNTHES RESORBABLE FIXATION SYSTEM | 02/24/1998 |
| K033160 | SYNTHES (USA) | SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES | 10/09/2003 |
| K020505 | SYNTHES (USA) | SYNTHES TRANSLATING MAXILLARY DISTRACTOR | 04/23/2002 |
| K063790 | SYNTHES (USA) | THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM | 04/16/2007 |
| K192655 | Synthes (USA) Products LLC | Depuy Synthes Maxillofacial Portfolio - MR Conditional | 12/30/2019 |
| K141165 | SYNTHES (USA) PRODUCTS LLC | MATRIXWAVE MMF SYSTEM | 10/17/2014 |
| K201944 | Synthes (USA) Products, LLC | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) | 09/10/2020 |
| K113567 | SYNTHES INC | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM | 11/19/2012 |
| K121574 | SYNTHES INC | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM | 06/29/2012 |
| K113251 | SYNTHES INC | SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES | 12/21/2011 |
| K122647 | SYNTHES INC | SYNTHES PATIENT SPECIFIC PLATE | 02/28/2013 |
| K061881 | TAKIRON CO., LTD | OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM | 03/14/2007 |
| K031989 | TEKKA | ORTRAUTEK ORTHOGNATHIC SYSTEM | 10/28/2003 |
| K032520 | TEKKA | ORTRAUTEK TRAUMA SYSTEM | 11/12/2003 |
| K993862 | THE STRAUMANN CO. | MODUS SAGITTAL SPLIT PLATE | 12/29/1999 |
| K021511 | UNICARE BIOMEDICAL, INC. | CYTOFLEX MESH | 08/06/2002 |
| K180204 | Visionare LLC | CranioMaxillofacial Fixation (CMF) System - CMF Visionare | 12/28/2018 |
| K972322 | WALTER LORENZ SURGICAL, INC. | LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES | 08/18/1997 |
| K980512 | WALTER LORENZ SURGICAL, INC. | LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW | 05/11/1998 |
| K030425 | WALTER LORENZ SURGICAL, INC. | LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER | 05/14/2004 |
| K002083 | WALTER LORENZ SURGICAL, INC. | LORENZ RESORBABLE DISTRACTOR SYSTEM | 02/12/2001 |
| K063052 | WALTER LORENZ SURGICAL, INC. | LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES | 01/12/2007 |
| K001238 | WALTER LORENZ SURGICAL, INC. | LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM | 05/03/2000 |
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