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 |
|---|---|---|---|
| Nov 29, 2007 | K072463 | SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM Satyrne Medical | JEY |
| Sep 11, 2007 | K071612 | MODUS TRILOCK 2.0/2.3/2.5 Medartis AG | JEY |
| Jul 30, 2007 | K062436 | SIS SINUS IMPLANT STABILIZER Mondeal Medical Systems GmbH, NL | JEY |
| Jul 25, 2007 | K070737 | XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES Prosurg, Inc. | JEY |
| Apr 16, 2007 | K063790 | THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM Synthes (Usa) | JEY |
| Mar 14, 2007 | K061881 | OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM Takiron Co., Ltd., JP | JEY |
| Feb 27, 2007 | K062789 | SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM Synthes (Usa) | JEY |
| Jan 12, 2007 | K063052 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES Walter Lorenz Surgical, Inc. | JEY |
| Sep 21, 2006 | K061507 | SONICWELD RX ENDOBROW FIXATION KLS-Martin L.P. | JEY |
| Apr 18, 2006 | K060177 | KLS MARTIN RIGID FIXATION - STERILE KLS Martin L.P. | JEY |
| Apr 7, 2006 | K060492 | AESCULAP CRANIOFACIAL PLATE AND SCREW Aesculap, Inc. | JEY |
| Sep 20, 2005 | K052444 | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM Inion , Ltd., FI | JEY |
| Aug 22, 2005 | K051236 | RESORB-X SF KLS-Martin L.P. | JEY |
| Jul 27, 2005 | K051845 | THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM Bioplate, Inc. | JEY |
| Jun 14, 2005 | K051293 | CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM Ceremed , Inc. | JEY |
| May 27, 2005 | K051341 | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059 Inion , Ltd., FI | JEY |
| May 26, 2005 | K050669 | JEIL BONE FIXATION SYSTEM Jeil Medical Corporation | JEY |
| May 18, 2005 | K050608 | SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM Synthes (Usa) | JEY |
| May 5, 2005 | K050934 | MODUS TITANIUM OSTEOSYNTHESIS SYSTEM Medartis, Inc. | JEY |
| Mar 4, 2005 | K050204 | SYNTHES RAPID RESORBABLE TACK SYSTEM Synthes (Usa) | JEY |
| Feb 23, 2005 | K043297 | MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM Medicon EG, NL | JEY |
| Nov 23, 2004 | K042987 | MODIFICATION TO SYNTHES CRANIAL PLATES Synthes (Usa) | JEY |
| Nov 18, 2004 | K042365 | SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM Synthes (Usa) | JEY |
| Oct 8, 2004 | K042517 | BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS Linvatec Biomaterials, Ltd., FI | JEY |
| Jun 3, 2004 | K040650 | BONAMATES SERIES Biotech One, Inc. | JEY |
| May 14, 2004 | K030425 | LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER Walter Lorenz Surgical, Inc. | JEY |
| Apr 21, 2004 | K033092 | THE GNATHOMETER Ortho Gnathics, LLC | JEY |
| Apr 1, 2004 | K030989 | OSTEOSORB TACK FIXATION SYSTEM Noviace Corporation | JEY |
| Feb 23, 2004 | K040272 | SYNTHES (USA) CRANIOFACIAL PLATES Synthes (Usa) | JEY |
| Nov 12, 2003 | K032520 | ORTRAUTEK TRAUMA SYSTEM Tekka | JEY |
| Oct 30, 2003 | K033194 | INION CPS BABY 1.5 BIOABSORBABLE SYSTEM Inion , Ltd., FI | JEY |
| Oct 28, 2003 | K031989 | ORTRAUTEK ORTHOGNATHIC SYSTEM Tekka | JEY |
| Oct 20, 2003 | K033121 | 1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES Synthes (Usa) | JEY |
| Oct 9, 2003 | K033160 | SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES Synthes (Usa) | JEY |
| Sep 10, 2003 | K031659 | UNIVERSAL NEURO SYSTEM Stryker Instruments | JEY |
| Sep 3, 2003 | K031761 | SYNTHES (USA) NEW/STERIAL ORBITAL PLATES Synthes (Usa) | JEY |
| May 9, 2003 | K030448 | OSTEOMED 2.0 LOCKING PLATES AND SCREWS Osteomed LP | JEY |
| Apr 28, 2003 | K031028 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Bioplate, Inc. | JEY |
| Apr 8, 2003 | K030806 | BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Bioplate, Inc. | JEY |
| Apr 8, 2003 | K030069 | SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM Synthes (Usa) | JEY |
| Jan 17, 2003 | K022035 | OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB Osteomedics, Inc. | JEY |
| Jan 7, 2003 | K022844 | SYNTHES RESORBABLE CONTOURABLE MESH Synthes (Usa) | JEY |
| Dec 17, 2002 | K022185 | UNIVERSAL CMF SYSTEM Stryker Instruments | JEY |
| Dec 4, 2002 | K023810 | MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Bioplate, Inc. | JEY |
| Nov 22, 2002 | K023665 | MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Bioplate, Inc. | JEY |
| Nov 1, 2002 | K022012 | SYNTHES LOW PROFILE NEURO SYSTEM Synthes (Usa) | JEY |
| Oct 31, 2002 | K023488 | OSSTAPLE, CRANIOFACIAL Biomedical Enterprises, Inc. | JEY |
| Oct 31, 2002 | K023486 | OSSTAPLE, MAXILLOFACIAL Biomedical Enterprises, Inc. | JEY |
| Sep 6, 2002 | K022890 | MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Bioplate, Inc. | JEY |
| Sep 6, 2002 | K021928 | SYNTHES (USA) RESORBABLE FIXATION SYSTEM Synthes (Usa) | JEY |
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