FDA Product Code
FDA Product Code JEY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.4760
510(k) Clearances — 294 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K072463 | SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM | Satyrne Medical | 2007-11-29 | Traditional | PDF ↗ |
| K071612 | MODUS TRILOCK 2.0/2.3/2.5 | Medartis AG | 2007-09-11 | Traditional | PDF ↗ |
| K062436 | SIS SINUS IMPLANT STABILIZER | Mondeal Medical Systems GmbH | 2007-07-30 | Traditional | PDF ↗ |
| K070737 | XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES | Prosurg, Inc. | 2007-07-25 | Traditional | PDF ↗ |
| K063790 | THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM | Synthes (Usa) | 2007-04-16 | Traditional | PDF ↗ |
| K061881 | OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM | Takiron Co., Ltd. | 2007-03-14 | Traditional | PDF ↗ |
| K062789 | SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM | Synthes (Usa) | 2007-02-27 | Traditional | PDF ↗ |
| K063052 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES | Walter Lorenz Surgical, Inc. | 2007-01-12 | Traditional | PDF ↗ |
| K061507 | SONICWELD RX ENDOBROW FIXATION | KLS-Martin L.P. | 2006-09-21 | Traditional | PDF ↗ |
| K060177 | KLS MARTIN RIGID FIXATION - STERILE | KLS Martin L.P. | 2006-04-18 | Traditional | PDF ↗ |
| K060492 | AESCULAP CRANIOFACIAL PLATE AND SCREW | Aesculap, Inc. | 2006-04-07 | Traditional | PDF ↗ |
| K052444 | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM | Inion , Ltd. | 2005-09-20 | Special | PDF ↗ |
| K051236 | RESORB-X SF | KLS-Martin L.P. | 2005-08-22 | Traditional | PDF ↗ |
| K051845 | THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM | Bioplate, Inc. | 2005-07-27 | Special | PDF ↗ |
| K051293 | CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM | Ceremed , Inc. | 2005-06-14 | Traditional | PDF ↗ |
| K051341 | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059 | Inion , Ltd. | 2005-05-27 | Special | PDF ↗ |
| K050669 | JEIL BONE FIXATION SYSTEM | Jeil Medical Corporation | 2005-05-26 | Traditional | PDF ↗ |
| K050608 | SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM | Synthes (Usa) | 2005-05-18 | Traditional | PDF ↗ |
| K050934 | MODUS TITANIUM OSTEOSYNTHESIS SYSTEM | Medartis, Inc. | 2005-05-05 | Special | PDF ↗ |
| K050204 | SYNTHES RAPID RESORBABLE TACK SYSTEM | Synthes (Usa) | 2005-03-04 | Traditional | PDF ↗ |
| K043297 | MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM | Medicon EG | 2005-02-23 | Special | PDF ↗ |
| K042987 | MODIFICATION TO SYNTHES CRANIAL PLATES | Synthes (Usa) | 2004-11-23 | Special | PDF ↗ |
| K042365 | SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM | Synthes (Usa) | 2004-11-18 | Traditional | PDF ↗ |
| K042517 | BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS | Linvatec Biomaterials, Ltd. | 2004-10-08 | Special | PDF ↗ |
| K040650 | BONAMATES SERIES | Biotech One, Inc. | 2004-06-03 | Traditional | PDF ↗ |
| K030425 | LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER | Walter Lorenz Surgical, Inc. | 2004-05-14 | Traditional | PDF ↗ |
| K033092 | THE GNATHOMETER | Ortho Gnathics, LLC | 2004-04-21 | Traditional | PDF ↗ |
| K030989 | OSTEOSORB TACK FIXATION SYSTEM | Noviace Corporation | 2004-04-01 | Traditional | PDF ↗ |
| K040272 | SYNTHES (USA) CRANIOFACIAL PLATES | Synthes (Usa) | 2004-02-23 | Special | PDF ↗ |
| K032520 | ORTRAUTEK TRAUMA SYSTEM | Tekka | 2003-11-12 | Traditional | PDF ↗ |
| K033194 | INION CPS BABY 1.5 BIOABSORBABLE SYSTEM | Inion , Ltd. | 2003-10-30 | Special | PDF ↗ |
| K031989 | ORTRAUTEK ORTHOGNATHIC SYSTEM | Tekka | 2003-10-28 | Traditional | PDF ↗ |
| K033121 | 1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES | Synthes (Usa) | 2003-10-20 | Special | PDF ↗ |
| K033160 | SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES | Synthes (Usa) | 2003-10-09 | Special | PDF ↗ |
| K031659 | UNIVERSAL NEURO SYSTEM | Stryker Instruments | 2003-09-10 | Traditional | PDF ↗ |
| K031761 | SYNTHES (USA) NEW/STERIAL ORBITAL PLATES | Synthes (Usa) | 2003-09-03 | Traditional | PDF ↗ |
| K030448 | OSTEOMED 2.0 LOCKING PLATES AND SCREWS | Osteomed LP | 2003-05-09 | Traditional | PDF ↗ |
| K031028 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Bioplate, Inc. | 2003-04-28 | Special | PDF ↗ |
| K030069 | SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM | Synthes (Usa) | 2003-04-08 | Traditional | PDF ↗ |
| K030806 | BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Bioplate, Inc. | 2003-04-08 | Special | PDF ↗ |
| K022035 | OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB | Osteomedics, Inc. | 2003-01-17 | Traditional | PDF ↗ |
| K022844 | SYNTHES RESORBABLE CONTOURABLE MESH | Synthes (Usa) | 2003-01-07 | Traditional | PDF ↗ |
| K022185 | UNIVERSAL CMF SYSTEM | Stryker Instruments | 2002-12-17 | Traditional | PDF ↗ |
| K023810 | MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Bioplate, Inc. | 2002-12-04 | Special | PDF ↗ |
| K023665 | MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Bioplate, Inc. | 2002-11-22 | Special | PDF ↗ |
| K022012 | SYNTHES LOW PROFILE NEURO SYSTEM | Synthes (Usa) | 2002-11-01 | Traditional | PDF ↗ |
| K023486 | OSSTAPLE, MAXILLOFACIAL | Biomedical Enterprises, Inc. | 2002-10-31 | Special | PDF ↗ |
| K023488 | OSSTAPLE, CRANIOFACIAL | Biomedical Enterprises, Inc. | 2002-10-31 | Special | PDF ↗ |
| K022890 | MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Bioplate, Inc. | 2002-09-06 | Special | PDF ↗ |
| K021928 | SYNTHES (USA) RESORBABLE FIXATION SYSTEM | Synthes (Usa) | 2002-09-06 | Traditional | PDF ↗ |
| K022005 | SYNTHES MIDFACE DISTRACTOR | Synthes (Usa) | 2002-09-03 | Traditional | PDF ↗ |
| K021642 | SYNTHES CRANIOFACIAL PLATES | Synthes (Usa) | 2002-08-14 | Traditional | PDF ↗ |
| K021618 | OSA RIGID INTERNAL FIXATION SYSTEM | Osteomed Corp. | 2002-08-08 | Traditional | PDF ↗ |
| K021511 | CYTOFLEX MESH | Unicare Biomedical, Inc. | 2002-08-06 | Traditional | PDF ↗ |
| K021342 | NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR | Osteomedics, Inc. | 2002-08-01 | Traditional | PDF ↗ |
| K021341 | NORMED BONE TRANSPORT DISTRACTION DEVICE | Osteomedics, Inc. | 2002-08-01 | Traditional | PDF ↗ |
| K022033 | STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM | Bioplate, Inc. | 2002-07-19 | Special | PDF ↗ |
| K021684 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Bioplate, Inc. | 2002-06-26 | Traditional | PDF ↗ |
| K021382 | SYNTHES (USA) AUTOMATED TACK DRIVER | Synthes (Usa) | 2002-05-16 | Special | PDF ↗ |
| K020505 | SYNTHES TRANSLATING MAXILLARY DISTRACTOR | Synthes (Usa) | 2002-04-23 | Traditional | PDF ↗ |
| K013672 | BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM | Azary Technologies, LLC | 2002-04-08 | Traditional | PDF ↗ |
| K011590 | RESORB-X RESORBABLE PLATING SYSTEM | KLS-Martin L.P. | 2002-03-20 | Traditional | PDF ↗ |
| K014263 | NEWGEN/UNIVERSAL MANDIBULAR SYSTEM | Stryker Instruments | 2002-03-08 | Special | PDF ↗ |
| K011569 | BIOSORBFX O/M 2.0/2/4 SYSTEM | Bionx Implants, Inc. | 2002-02-22 | Traditional | PDF ↗ |
| K020087 | SYNTHES CRANIAL PLATES | Synthes (Usa) | 2002-02-20 | Traditional | PDF ↗ |
| K013055 | THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM | Bioplate, Inc. | 2001-12-07 | Traditional | PDF ↗ |
| K012910 | THE BIOPLATE MANDIBLE FIXATION SYSTEM | Bioplate, Inc. | 2001-11-20 | Traditional | PDF ↗ |
| K013039 | INION CPS 2.0 ORTHOGNATHIC PLATE | Inion , Ltd. | 2001-10-05 | Special | PDF ↗ |
| K012413 | MACROPORE FX, PS, NS, LP | Macropore Biosurgery, Inc. | 2001-09-18 | Traditional | PDF ↗ |
| K011698 | STRAUMANN GBR SYSTEM | Institut Straumann AG | 2001-08-23 | Traditional | PDF ↗ |
| K010118 | NORMED MANDIBULAR FIXATION SYSTEM | Osteomedics, Inc. | 2001-08-14 | Traditional | PDF ↗ |
| K003281 | LACTOSORB RAPIDFLAP | Biomet, Inc. | 2001-08-07 | Traditional | PDF ↗ |
| K002207 | MACROPOREPX PEDIATRIC SYSTEM | Macropore Biosurgery, Inc. | 2001-07-11 | Traditional | PDF ↗ |
| K011380 | MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM | Bioplate, Inc. | 2001-05-14 | Special | PDF ↗ |
| K010499 | SYNTHES (USA) MIDFACE DISTRACTOR | Synthes (Usa) | 2001-05-03 | Traditional | PDF ↗ |
| K010351 | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM | Inion , Ltd. | 2001-03-15 | Traditional | PDF ↗ |
| K010687 | BIOSORBFX AND BIOSORBPDX MESH | Bionx Implants, Inc. | 2001-03-14 | Special | PDF ↗ |
| K010352 | CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM | Inion , Ltd. | 2001-03-14 | Traditional | PDF ↗ |
| K003786 | SMF RESORBABLE MESHES AND SHEETS | Synthes (Usa) | 2001-02-27 | Traditional | PDF ↗ |
| K003549 | CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS | Codman & Shurtleff, Inc. | 2001-02-15 | Traditional | PDF ↗ |
| K002083 | LORENZ RESORBABLE DISTRACTOR SYSTEM | Walter Lorenz Surgical, Inc. | 2001-02-12 | Traditional | PDF ↗ |
| K003757 | THERMOFX MESH | Bionx Implants, Ltd. | 2001-02-07 | Traditional | PDF ↗ |
| K002426 | THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY | Bioplate, Inc. | 2001-01-26 | Traditional | PDF ↗ |
| K994060 | THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE | Bioplate, Inc. | 2001-01-24 | Traditional | PDF ↗ |
| K003883 | MOLINA ORBITAL MALAR DISTRACTOR | KLS-Martin L.P. | 2001-01-23 | Traditional | PDF ↗ |
| K003393 | MAXILLARY DISTRACTOR | Synthes (Usa) | 2001-01-17 | Traditional | PDF ↗ |
| K000560 | SYNTHES (USA) RESORBABLE TACK SYSTEM | Synthes (Usa) | 2001-01-09 | Traditional | PDF ↗ |
| K003756 | BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES | Bionx Implants, Inc. | 2001-01-03 | Special | PDF ↗ |
| K003660 | LEIBINGER NEURO CLIP SYSTEM | Stryker Instruments | 2000-12-12 | Special | PDF ↗ |
| K000594 | LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE | Stryker Leibinger | 2000-12-08 | Traditional | PDF ↗ |
| K002798 | CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS | Codman & Shurtleff, Inc. | 2000-12-06 | Traditional | PDF ↗ |
| K002619 | NEWGEN SYSTEM | Stryker Instruments | 2000-11-16 | Traditional | PDF ↗ |
| K000696 | MACROPOREMX MANDIBULAR FIXATION SYSTEM | Macropore Biosurgery, Inc. | 2000-10-19 | Traditional | PDF ↗ |
| K002879 | MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM | Bioplate, Inc. | 2000-10-05 | Special | PDF ↗ |
| K992905 | CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM | Codman & Shurtleff, Inc. | 2000-08-01 | Traditional | PDF ↗ |
| K001530 | THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM | Bioplate, Inc. | 2000-07-21 | Traditional | PDF ↗ |
| K001219 | MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM | Biomedical Ent., Inc. | 2000-06-21 | Traditional | PDF ↗ |
| K000836 | BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM | Bionx Implants, Inc. | 2000-06-08 | Traditional | PDF ↗ |
| K001238 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM | Walter Lorenz Surgical, Inc. | 2000-05-03 | Special | PDF ↗ |
| K994154 | MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES | KLS-Martin L.P. | 2000-02-15 | Traditional | PDF ↗ |
Product code JEY · Class II · Dental. Data: openFDA.