Plate, Bone
Regulation 872.4760
4510(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 |
|---|---|---|---|
| Dec 29, 1999 | K993862 | MODUS SAGITTAL SPLIT PLATE The Straumann Co. | JEY |
| Nov 24, 1999 | K992683 | MODUS 2.5 MANDIBULAR TRAUMA SET Medartis AG | JEY |
| Nov 24, 1999 | K992682 | MODUS 2.5 MANDIBULAR RECONSTRUCTION SET Medartis AG | JEY |
| Nov 23, 1999 | K992330 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Biomedics | JEY |
| Aug 20, 1999 | K992158 | LACTOSORB SHEETS Biomet, Inc. | JEY |
| Jun 10, 1999 | K990920 | DRG TITANIUM BONE PLATE Doctor'S Research Group, Inc. | JEY |
| Mar 25, 1999 | K990140 | NORMED BONE TRANSPORT Ace Surgical Supply Co., Inc. | JEY |
| Mar 19, 1999 | K983360 | MACROPORE PROTECTIVE SHEET Pacific Materials and Interfaces | JEY |
| Feb 17, 1999 | K982721 | BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM Bionx Implants, Inc. | JEY |
| Feb 4, 1999 | K984230 | OSTEO-MESH TM-300 Osteogenics Biomedical, Inc. | JEY |
| Jan 29, 1999 | K983885 | BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES Howmedica, Inc. | JEY |
| Dec 29, 1998 | K983535 | THE TITANIUM MINIPLATING SYSTEM, THE TITANIUM MICROPLATING SYSTEM, THE TITANIUM MEDIUMPLATING SYSTEM, MODEL #'S H12-1010 Hans Hermann GmbH, DE | JEY |
| Dec 23, 1998 | K983528 | MICRO DYNAMIC MESH Howmedica Corp. | JEY |
| Nov 6, 1998 | K981526 | ACE ALVEOLAR DISTRACTOR Ace Surgical Supply Co., Inc. | JEY |
| Sep 15, 1998 | K982139 | BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM Bionx Implants, Inc. | JEY |
| Aug 18, 1998 | K981890 | SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES Synthes (Usa) | JEY |
| Jun 9, 1998 | K980983 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Biomedics | JEY |
| Jun 5, 1998 | K980927 | LACTOSORB PANELS AND FASTENERS Biomet, Inc. | JEY |
| May 20, 1998 | K981070 | 20-HOLE ADAPTATION PLATE Biomet, Inc. | JEY |
| May 11, 1998 | K980512 | LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW Walter Lorenz Surgical, Inc. | JEY |
| May 7, 1998 | K973924 | FRIOS BONESHIELD Friatec AG | JEY |
| Mar 3, 1998 | K974555 | SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS) Synthes (Usa) | JEY |
| Feb 24, 1998 | K974554 | SYNTHES RESORBABLE FIXATION SYSTEM Synthes (Usa) | JEY |
| Dec 2, 1997 | K973484 | CHIN DISTRACTOR Howmedica, Inc. | JEY |
| Nov 19, 1997 | K973145 | TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM Sofamor Danek USA,Inc. | JEY |
| Sep 25, 1997 | K972463 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Biomedics | JEY |
| Aug 18, 1997 | K972322 | LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES Walter Lorenz Surgical, Inc. | JEY |
| Aug 11, 1997 | K972166 | GUERRERO - BELL DISTRACTOR Howmedica Leibinger, Inc. | JEY |
| Aug 11, 1997 | K972154 | COHEN DISTRACTOR Howmedica Leibinger, Inc. | JEY |
| Jun 24, 1997 | K971987 | SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR Synthes (Usa) | JEY |
| Apr 30, 1997 | K970841 | IMTEC/TITANIUM MESH Imtec Corp. | JEY |
| Apr 11, 1997 | K970911 | LEE PLATE Howmedica Leibinger, Inc. | JEY |
| Mar 11, 1997 | K970256 | INTRAORAL MANDIBULAR DISTRACTION DEVICE Medicon EG | JEY |
| Jan 24, 1997 | K964649 | VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE Howmedica Leibinger, Inc. | JEY |
| Dec 13, 1996 | K964328 | SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE Synthes (Usa) | JEY |
| Nov 14, 1996 | K963394 | OSTEOMED TRAM Osteomed Corp. | JEY |
| Oct 28, 1996 | K963740 | LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS Howmedica Leibinger, Inc. | JEY |
| Aug 16, 1996 | K961976 | THE BIOPLATE FIXATION SYSTEM Biomedics | JEY |
| Jun 26, 1996 | K961421 | SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM Synthes (Usa) | JEY |
| Apr 15, 1996 | K960514 | TMP MANDIBULAR COMPRESSION SYSTEM (MODIFICATION) Anspach Fixation Systems | JEY |
| Apr 4, 1996 | K960914 | 3I OSSEOUS FIXATION SYSTEM(S) Implant Innovations, Inc. | JEY |
| Mar 8, 1996 | K954385 | SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM Synthes (Usa) | JEY |
| Mar 8, 1996 | K953806 | SYNTHES (USA) MIDFACIAL SYSTEM Synthes (Usa) | JEY |
| Sep 29, 1995 | K953273 | BIOPLATE RIGID FIXATION BONE PLATING SYSTEM Biomedics | JEY |
| Sep 28, 1995 | K953385 | LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM Walter Lorenz Surgical, Inc. | JEY |
| Sep 21, 1995 | K945500 | WELLS JOHNSON FIXATION SYSTEM Wells Johnson Co. | JEY |
| Sep 15, 1995 | K953386 | 9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS Implant Innovations, Inc. | JEY |
| Aug 30, 1995 | K952812 | 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM) BONE-MESH/PLATE & SCREWS Implant Innovations, Inc. | JEY |
| Aug 30, 1995 | K952811 | 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: STAINLESS STEEL BONE-MESH/PLATE & SCREWS Implant Innovations, Inc. | JEY |
| Jul 27, 1995 | K951689 | TITANIUM MANDIBULAT RECONSTRUCTION SYSTEM Medicon EG | JEY |
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