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 |
|---|---|---|---|
| Sep 3, 2002 | K022005 | SYNTHES MIDFACE DISTRACTOR Synthes (Usa) | JEY |
| Aug 14, 2002 | K021642 | SYNTHES CRANIOFACIAL PLATES Synthes (Usa) | JEY |
| Aug 8, 2002 | K021618 | OSA RIGID INTERNAL FIXATION SYSTEM Osteomed Corp. | JEY |
| Aug 6, 2002 | K021511 | CYTOFLEX MESH Unicare Biomedical, Inc. | JEY |
| Aug 1, 2002 | K021342 | NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR Osteomedics, Inc. | JEY |
| Aug 1, 2002 | K021341 | NORMED BONE TRANSPORT DISTRACTION DEVICE Osteomedics, Inc. | JEY |
| Jul 19, 2002 | K022033 | STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM Bioplate, Inc. | JEY |
| Jun 26, 2002 | K021684 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Bioplate, Inc. | JEY |
| May 16, 2002 | K021382 | SYNTHES (USA) AUTOMATED TACK DRIVER Synthes (Usa) | JEY |
| Apr 23, 2002 | K020505 | SYNTHES TRANSLATING MAXILLARY DISTRACTOR Synthes (Usa) | JEY |
| Apr 8, 2002 | K013672 | BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM Azary Technologies, LLC | JEY |
| Mar 20, 2002 | K011590 | RESORB-X RESORBABLE PLATING SYSTEM KLS-Martin L.P. | JEY |
| Mar 8, 2002 | K014263 | NEWGEN/UNIVERSAL MANDIBULAR SYSTEM Stryker Instruments | JEY |
| Feb 22, 2002 | K011569 | BIOSORBFX O/M 2.0/2/4 SYSTEM Bionx Implants, Inc., FI | JEY |
| Feb 20, 2002 | K020087 | SYNTHES CRANIAL PLATES Synthes (Usa) | JEY |
| Dec 7, 2001 | K013055 | THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM Bioplate, Inc. | JEY |
| Nov 20, 2001 | K012910 | THE BIOPLATE MANDIBLE FIXATION SYSTEM Bioplate, Inc. | JEY |
| Oct 5, 2001 | K013039 | INION CPS 2.0 ORTHOGNATHIC PLATE Inion , Ltd., FI | JEY |
| Sep 18, 2001 | K012413 | MACROPORE FX, PS, NS, LP Macropore Biosurgery, Inc. | JEY |
| Aug 23, 2001 | K011698 | STRAUMANN GBR SYSTEM Institut Straumann AG | JEY |
| Aug 14, 2001 | K010118 | NORMED MANDIBULAR FIXATION SYSTEM Osteomedics, Inc. | JEY |
| Aug 7, 2001 | K003281 | LACTOSORB RAPIDFLAP Biomet, Inc. | JEY |
| Jul 11, 2001 | K002207 | MACROPOREPX PEDIATRIC SYSTEM Macropore Biosurgery, Inc. | JEY |
| May 14, 2001 | K011380 | MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM Bioplate, Inc. | JEY |
| May 3, 2001 | K010499 | SYNTHES (USA) MIDFACE DISTRACTOR Synthes (Usa) | JEY |
| Mar 15, 2001 | K010351 | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM Inion , Ltd., FI | JEY |
| Mar 14, 2001 | K010687 | BIOSORBFX AND BIOSORBPDX MESH Bionx Implants, Inc., FI | JEY |
| Mar 14, 2001 | K010352 | CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM Inion , Ltd., FI | JEY |
| Feb 27, 2001 | K003786 | SMF RESORBABLE MESHES AND SHEETS Synthes (Usa) | JEY |
| Feb 15, 2001 | K003549 | CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS Codman & Shurtleff, Inc. | JEY |
| Feb 12, 2001 | K002083 | LORENZ RESORBABLE DISTRACTOR SYSTEM Walter Lorenz Surgical, Inc. | JEY |
| Feb 7, 2001 | K003757 | THERMOFX MESH Bionx Implants, Ltd., FI | JEY |
| Jan 26, 2001 | K002426 | THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY Bioplate, Inc. | JEY |
| Jan 24, 2001 | K994060 | THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE Bioplate, Inc. | JEY |
| Jan 23, 2001 | K003883 | MOLINA ORBITAL MALAR DISTRACTOR KLS-Martin L.P. | JEY |
| Jan 17, 2001 | K003393 | MAXILLARY DISTRACTOR Synthes (Usa) | JEY |
| Jan 9, 2001 | K000560 | SYNTHES (USA) RESORBABLE TACK SYSTEM Synthes (Usa) | JEY |
| Jan 3, 2001 | K003756 | BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES Bionx Implants, Inc. | JEY |
| Dec 12, 2000 | K003660 | LEIBINGER NEURO CLIP SYSTEM Stryker Instruments | JEY |
| Dec 8, 2000 | K000594 | LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE Stryker Leibinger | JEY |
| Dec 6, 2000 | K002798 | CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS Codman & Shurtleff, Inc. | JEY |
| Nov 16, 2000 | K002619 | NEWGEN SYSTEM Stryker Instruments | JEY |
| Oct 19, 2000 | K000696 | MACROPOREMX MANDIBULAR FIXATION SYSTEM Macropore Biosurgery, Inc. | JEY |
| Oct 5, 2000 | K002879 | MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM Bioplate, Inc. | JEY |
| Aug 1, 2000 | K992905 | CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM Codman & Shurtleff, Inc. | JEY |
| Jul 21, 2000 | K001530 | THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM Bioplate, Inc. | JEY |
| Jun 21, 2000 | K001219 | MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM Biomedical Ent., Inc. | JEY |
| Jun 8, 2000 | K000836 | BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM Bionx Implants, Inc., FI | JEY |
| May 3, 2000 | K001238 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM Walter Lorenz Surgical, Inc. | JEY |
| Feb 15, 2000 | K994154 | MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES KLS-Martin L.P. | JEY |
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