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 |
|---|---|---|---|
| Jul 27, 1995 | K951687 | MESH TITANIUM IMPLANT SYSTEM Medicon EG | JEY |
| Jul 26, 1995 | K951691 | CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEM Medicon EG | JEY |
| Jul 26, 1995 | K951690 | TITANIUM MINIPLATE SYSTEM Medicon EG | JEY |
| Jul 26, 1995 | K951688 | MICRO TITANIUM PLATE SYSTEM Medicon EG | JEY |
| Jul 12, 1995 | K950595 | LUHR MANDIBULAR/SMALL FIXATION IMPLANTS Howmedica Corp. | JEY |
| Jun 22, 1995 | K952168 | TITANIUM MANDIBULAR FRACTURE SYSTEM Medicon, Inc., DE | JEY |
| May 5, 1995 | K951392 | MINIBONEPLATE SYSTEM Ace Surgical Supply Co., Inc. | JEY |
| Mar 23, 1995 | K950045 | KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM Karl Leibinger GmbH U. Co. KG | JEY |
| Jan 6, 1995 | K943071 | THE TITANIUM FIXATION SYSTEM Biomedics | JEY |
| Oct 18, 1994 | K944565 | KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM) KLS-Martin L.P. | JEY |
| Oct 18, 1994 | K944561 | MICRO OSTEOSYNTHESIS SYSTEM (1.0) KLS-Martin L.P. | JEY |
| Oct 18, 1994 | K944560 | MAN SURG INSTR/ACCESS TO KLS-MARTIN MICRO OSTEO SYST KLS-Martin L.P. | JEY |
| Oct 4, 1994 | K943348 | KLS CHIN PLATE SYSTEM Patton, Boggs & Blow | JEY |
| Oct 4, 1994 | K943347 | KLS MINI OSTEOSYNTHESIS SYSTEM Patton, Boggs & Blow | JEY |
| Oct 4, 1994 | K943346 | MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM Patton, Boggs & Blow | JEY |
| Oct 4, 1994 | K943345 | MANUAL SURGICAL INST. AND ACC. TO KLS CHIN PLATE SYSTEM Patton, Boggs & Blow | JEY |
| Jul 5, 1994 | K931539 | NORMED TITANIUM MINIPLATE SYSTEM Normed Medizin-Technik GmbH | JEY |
| Feb 1, 1994 | K923705 | AESCULAP CRANIOFACIAL TITANIUM PLATES AND SCREWS Aesculap, Inc. | JEY |
| Oct 5, 1993 | K932492 | IMPLANTOLOGY MODULE, MODEL 2175 Micro Surgical Instruments Corp. | JEY |
| Apr 8, 1993 | K923419 | TISMESH SYSTEM Ti-Mesh, Inc. | JEY |
| Feb 17, 1993 | K924138 | OSTEOMED M3 SYSTEM (SBF SYSTEM) Osteomed Corp. | JEY |
| Dec 23, 1992 | K922741 | LORENZ 1.0 MM SYSTEM Walter Lorenz Surgical, Inc. | JEY |
| Oct 26, 1992 | K923802 | TIMESH TITANIUM MINI-SOFTPLATE/SCREW Ti-Mesh, Inc. | JEY |
| Jul 15, 1992 | K921801 | MODIFICATION TECHMEDICA MP (MINIPLATING) SYSTEM Techmedica, Inc. | JEY |
| May 5, 1992 | K913688 | BUD MAXILLOFACIAL IMPLANT SYSTEM Bud Industries, Inc. | JEY |
| Feb 20, 1991 | K910038 | LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM Walter Lorenz Surgical, Inc. | JEY |
| Sep 6, 1990 | K901941 | LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES Howmedica Corp. | JEY |
| Sep 6, 1990 | K901940 | LUHR MICRO MESH Howmedica Corp. | JEY |
| Apr 27, 1990 | K901095 | BI-PHASE SET, ORAL, MAXILLOFACIAL SURGERY Grimm & Norton | JEY |
| Apr 27, 1990 | K901094 | HEAD FRAME KIT, ORAL MAXILLOFACIAL SURGERY Grimm & Norton | JEY |
| Apr 16, 1990 | K896404 | TITAMED ANTWERP SYSTEM Optik | JEY |
| Dec 8, 1988 | K884523 | MARTIN-CHAMPY TITAN SET Buschmann Surgical Products | JEY |
| Feb 19, 1988 | K873926 | STORZ CONTOURED ANATOMICAL PLATING INSTRUMENT Storz Instrument Co. | JEY |
| Jul 17, 1987 | K870041 | FLEXIBLE FASCICULATED BONE PLATE The Deca Co. | JEY |
| Sep 5, 1986 | K862532 | DUMBACH TITANIUM MESH IMPLANT SYSTEM Walter Lorenz Surgical, Inc. | JEY |
| Aug 7, 1986 | K862534 | PAULUS TITANIUM MINI BONE PLATES & BONE SCREWS Walter Lorenz Surgical, Inc. | JEY |
| Aug 7, 1986 | K862505 | MANUAL SURG. INSTRU. FOR PAULUS TITANIUM SYSTEM Walter Lorenz Surgical, Inc. | JEY |
| Aug 1, 1986 | K862533 | MANUAL SURG. INSTRU. FOR STEINHAUSER BONE PLATE Walter Lorenz Surgical, Inc. | JEY |
| Jul 25, 1986 | K862482 | STEINHAUSER TITANIUM MINI BONE PLATES & SCREWS Walter Lorenz Surgical, Inc. | JEY |
| Jul 16, 1986 | K862139 | IMTECH FIXATION SYSTEMS Imtech, Inc. | JEY |
| Feb 4, 1986 | K855224 | ACROMED NESTED BONE PLATE Buckman Co., Inc. | JEY |
| Jan 30, 1986 | K855030 | CHAMPY BONE PLATES & BONE SCREWS Advanced Biosearch Assn. | JEY |
| Jan 21, 1986 | K854886 | WUERZBURG TITANIUM MINI BONE PLATES & BONE SCREWS Walter Lorenz Surgical, Inc. | JEY |
| Jun 19, 1984 | K840955 | CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD Synthes (Usa) | JEY |
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