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 |