Plate, Bone
Regulation 872.4760
5510(k)s in 12 months (294 all time)
0recalls in 12 months (111 all time)
27recalls that name a 510(k)
Top companies in JEY
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Craniomaxillofacial Division | 0 | 81 |
| Synthes (Usa) | 42 | 2 |
| KLS Martin L.P. | 19 | 0 |
| Bioplate, Inc. | 16 | 2 |
| Walter Lorenz Surgical, Inc. | 15 | 3 |
| Biomet Microfixation | 8 | 7 |
| Stryker | 13 | 0 |
| Inion , Ltd. | 8 | 0 |
| Bionx Implants, Inc. | 7 | 0 |
| Medicon EG | 7 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 1, 2015 | K143338 | Argulated Locking Plates Osteomed LP | JEY |
| Apr 1, 2015 | K143336 | Biomet Microfixation OmniMax MMF System Biomet Microfixation | JEY |
| Jan 20, 2015 | K140037 | OPTIMUS CMF SYSTEM Osteonic Co., Ltd., KR | JEY |
| Dec 18, 2014 | K141764 | TRISTAR BONE GRAFT FIXATION SYSTEM Impladent , Ltd. | JEY |
| Dec 18, 2014 | K140978 | OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM Osteomed | JEY |
| Oct 17, 2014 | K141165 | MATRIXWAVE MMF SYSTEM Synthes (USA) Products, LLC | JEY |
| Aug 1, 2014 | K133461 | STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM Stryker | JEY |
| May 15, 2014 | K133304 | RXG DISTRACTION SYSTEM KLS-Martin L.P. | JEY |
| Jan 9, 2014 | K121235 | LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM Stryker | JEY |
| Dec 6, 2013 | K132519 | STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT Stryker | JEY |
| Oct 2, 2013 | K132600 | FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING Biomet Microfixation | JEY |
| Sep 25, 2013 | K131289 | I-GEN Megagen Implant Co., Ltd. | JEY |
| Sep 18, 2013 | K130840 | SMARTBUILDER SYSTEM (SB1) Osstem Implant Co., Ltd. | JEY |
| Aug 8, 2013 | K131674 | PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING Biomet Microfixation | JEY |
| Apr 9, 2013 | K123786 | STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM Stryker | JEY |
| Feb 28, 2013 | K122647 | SYNTHES PATIENT SPECIFIC PLATE Synthes, Inc. | JEY |
| Jan 29, 2013 | K122890 | INION CPS ORBITAL PLATES Inion OY, FI | JEY |
| Nov 19, 2012 | K113567 | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM Synthes, Inc. | JEY |
| Oct 31, 2012 | K122313 | STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM Stryker | JEY |
| Oct 3, 2012 | K120951 | SMARTBUILDER SYSTEM Osstem Implant Co., Ltd. | JEY |
| Sep 21, 2012 | K121589 | BIOMET MICROFIXATION FACIAL PLATING SYSTEM Biomet Microfixation | JEY |
| Jun 29, 2012 | K121574 | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM Synthes, Inc. | JEY |
| Jun 29, 2012 | K113512 | BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM Biomet Microfixation | JEY |
| May 30, 2012 | K120271 | ARTISAN SPACE MAINTENANCE SYSTEM Medtronic Sofamor Danek USA, Inc. | JEY |
| May 18, 2012 | K112457 | LEFORTE SYSTEM BONE PLATE & SCREW Arkin Consulting Group | JEY |
| Mar 23, 2012 | K112064 | RESORB X-G KLS-Martin L.P. | JEY |
| Jan 10, 2012 | K111761 | NEO TITANIUM MESH, CTI-MEM Neobiotech Co., Ltd. | JEY |
| Dec 21, 2011 | K113251 | SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES Synthes, Inc. | JEY |
| Dec 8, 2011 | K110926 | BONE PLATE; BONE SCREW Biomaterials Korea, Inc. | JEY |
| Apr 13, 2011 | K110259 | ARCHITEX SPACE MAINTENANCE SYSTEM Medtronic Sofamor Danek USA, Inc. | JEY |
| Mar 18, 2011 | K103136 | SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE Materialise NV, BE | JEY |
| Jan 26, 2011 | K103778 | LEFORTE NEURO SYSTEM BONE PLATE Jeil Medical Corporation | JEY |
| Dec 20, 2010 | K102656 | SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM Synthes (Usa) | JEY |
| Dec 20, 2010 | K102641 | MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE Neoortho Produtos Ortopedicos S/A | JEY |
| Dec 13, 2010 | K100779 | SUSTAIN SPACE MAINTENANCE SYSTEM Medtronic Sofamor Danek USA, Inc. | JEY |
| Jun 28, 2010 | K091807 | MEDPOR FIXATION SYSTEM Porex Surgical, Inc. | JEY |
| May 7, 2010 | K091812 | FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS Frontier Devices, Inc. | JEY |
| Jan 15, 2010 | K092743 | THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM Stryker Craniomaxillofacial | JEY |
| Dec 11, 2009 | K091233 | SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES Synthes (Usa) | JEY |
| Oct 2, 2009 | K091679 | LEFORTE SYSTEM BONE PLATE Jeil Medical Corporation | JEY |
| Aug 25, 2009 | K091144 | SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES Synthes (Usa) | JEY |
| Mar 12, 2009 | K083388 | SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM Synthes (Usa) | JEY |
| Nov 10, 2008 | K082335 | SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM Synthes (Usa) | JEY |
| Oct 29, 2008 | K073307 | MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM Bio-Technology USA, Inc. | JEY |
| Oct 1, 2008 | K082757 | MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM Bioplate, Inc. | JEY |
| Jul 21, 2008 | K080862 | SONICWELD RX (RESORB-X) KLS-Martin L.P. | JEY |
| May 15, 2008 | K080694 | OSTEOMED MODULAR LOCKING FIXATION SYSTEM Osteomed LP | JEY |
| May 9, 2008 | K081067 | FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) Biomet Microfixation, Inc. | JEY |
| Apr 30, 2008 | K080331 | SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM Synthes (Usa) | JEY |
| Dec 28, 2007 | K072528 | ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES Prosurg, Inc. | JEY |
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