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 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2026-08-17 | Traditional | PDF ↗ |
| K253206 | METICULY Patient-specific CMF solution | Meticuly Co., Ltd. | 2026-07-25 | Traditional | PDF ↗ |
| K252246 | Leforte MMF System | Jeil Medical Corporation | 2026-04-02 | Traditional | PDF ↗ |
| K253373 | Southern Craniomaxillofacial (CMF) System | Southern Medical (Pty) , Ltd. | 2025-12-19 | Traditional | PDF ↗ |
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | Inion OY | 2025-11-07 | Traditional | PDF ↗ |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | KLS-Martin L.P. | 2024-08-16 | Traditional | PDF ↗ |
| K240651 | MRI Universal | Stryker Leibinger GmbH & Co KG | 2024-07-12 | Traditional | PDF ↗ |
| K233874 | tmCMF Solution | Techmah Cmf | 2024-07-11 | Traditional | PDF ↗ |
| K232889 | METICULY Patient-specific titanium maxillofacial mesh implant | Meticuly Co., Ltd. | 2024-04-30 | Traditional | PDF ↗ |
| K232350 | Stryker Facial iD System | Stryker Craniomaxillofacial | 2024-01-13 | Traditional | PDF ↗ |
| K230398 | MedCAD® AccuPlate® 3DTi Patient-Specific Plating System | Medcad | 2023-09-26 | Traditional | PDF ↗ |
| K230733 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | 2023-08-05 | Traditional | PDF ↗ |
| K222650 | Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate | Stryker Craniomaxillofacial (Cmf) | 2022-12-09 | Traditional | PDF ↗ |
| K220360 | Tandry CMF Plate System | Microware Precision Co., Ltd. | 2022-11-10 | Traditional | PDF ↗ |
| K221855 | Universal CMF System | Stryker Leibinger GmbH & Co KG | 2022-11-09 | Traditional | PDF ↗ |
| K210731 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2022-07-18 | Traditional | PDF ↗ |
| K213777 | Stryker Resorbable Fixation System | Stryker Leibinger Micro Implants | 2022-02-04 | Special | PDF ↗ |
| K202969 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | 2021-08-05 | Traditional | PDF ↗ |
| K202918 | OsteoSync Ti Dental Mesh | Sites Medical, LLC | 2021-07-14 | Traditional | PDF ↗ |
| K203282 | TECHFIT Patient-Specific Maxillofacial System | Industrias Medicas Sampedro S.A.S | 2021-05-19 | Traditional | PDF ↗ |
| K193280 | MedCAD® AccuPlate® Patient-Specific Plate | Medcad | 2021-02-12 | Traditional | PDF ↗ |
| K201944 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) | Synthes (USA) Products, LLC | 2020-09-10 | Special | PDF ↗ |
| K182759 | BoniPlus Dental G-Mesh System | Montjade Engineering Co., Ltd. | 2020-07-29 | Traditional | PDF ↗ |
| K192747 | Yxoss CBR® | Reoss GmbH | 2020-06-17 | Traditional | PDF ↗ |
| K191997 | FAICO CMF System | Faico Medical, LLC | 2020-04-22 | Traditional | PDF ↗ |
| K193136 | Stryker Customized Mandible Recon Plate Kit | Stryker | 2020-03-26 | Special | PDF ↗ |
| K193143 | Stryker Facial iD Plating System | Stryker | 2020-03-26 | Special | PDF ↗ |
| K192655 | Depuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | 2019-12-30 | Traditional | PDF ↗ |
| K182758 | MCI - CMF System | Mci Medical Concept Innovation, Inc. | 2019-12-05 | Traditional | PDF ↗ |
| K191028 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2019-11-22 | Traditional | PDF ↗ |
| K190696 | Stryker Surgeon iD Mandible Recon Plate | Stryker | 2019-06-28 | Special | PDF ↗ |
| K182609 | Delphos Implants Rigid Fixation System | Delphos Implants - Ind.Com. Importacao E Exportacao DE | 2019-03-29 | Traditional | PDF ↗ |
| K182305 | Stryker Facial iD Plating System | Stryker | 2019-01-07 | Traditional | PDF ↗ |
| K180204 | CranioMaxillofacial Fixation (CMF) System - CMF Visionare | Visionare, LLC | 2018-12-28 | Traditional | PDF ↗ |
| K180249 | OmniPore DUROMAX Surgical Implants | Matrix Surgical Holdings, LLC/Matrix Surgical USA | 2018-10-11 | Traditional | PDF ↗ |
| K180962 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2018-08-13 | Traditional | PDF ↗ |
| K173039 | TruMatch CMF Titanium 3D Printed Implant | Materialise NV | 2018-07-10 | Traditional | PDF ↗ |
| K170697 | GBR system | Surgident | 2018-05-24 | Traditional | PDF ↗ |
| K172354 | OssBuilder System | Osstem Implant Co., Ltd. | 2018-03-26 | Traditional | PDF ↗ |
| K173320 | KLS Martin L1 MMF System | KLS Martin L.P. | 2018-02-23 | Traditional | PDF ↗ |
| K163579 | KLS Martin Individual Patient Solutions | KLS Martin L.P. | 2017-11-21 | Traditional | PDF ↗ |
| K170773 | Stryker Universal Mesh | Stryker | 2017-11-08 | Traditional | PDF ↗ |
| K172572 | Stryker Upper-Face AXS screws and Mid-Face AXS screws | Stryker | 2017-10-31 | Special | PDF ↗ |
| K170272 | TruMatch CMF Titanium 3D Printed Implant System | Materialise NV | 2017-08-08 | Traditional | PDF ↗ |
| K171364 | MP LeFort I Plates | Stryker | 2017-07-24 | Special | PDF ↗ |
| K160363 | OPTIMUS CMF SYSTEM | Osteonic Co., Ltd. | 2016-10-20 | Special | PDF ↗ |
| K152326 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | 2015-12-10 | Traditional | PDF ↗ |
| K150965 | LeForte System II | Jeil Medical Corporation | 2015-09-17 | Traditional | PDF ↗ |
| K143730 | GBR System | Jeil Medical Corporation | 2015-06-10 | Traditional | PDF ↗ |
| K142568 | Stryker MEDPOR TITAN 3D Orbital Floor Implant | Stryker | 2015-05-05 | Traditional | PDF ↗ |
| K143338 | Argulated Locking Plates | Osteomed LP | 2015-04-01 | Special | PDF ↗ |
| K143336 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | 2015-04-01 | Traditional | PDF ↗ |
| K140037 | OPTIMUS CMF SYSTEM | Osteonic Co., Ltd. | 2015-01-20 | Traditional | PDF ↗ |
| K140978 | OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM | Osteomed | 2014-12-18 | Traditional | PDF ↗ |
| K141764 | TRISTAR BONE GRAFT FIXATION SYSTEM | Impladent , Ltd. | 2014-12-18 | Traditional | PDF ↗ |
| K141165 | MATRIXWAVE MMF SYSTEM | Synthes (USA) Products, LLC | 2014-10-17 | Traditional | PDF ↗ |
| K133461 | STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM | Stryker | 2014-08-01 | Traditional | PDF ↗ |
| K133304 | RXG DISTRACTION SYSTEM | KLS-Martin L.P. | 2014-05-15 | Traditional | PDF ↗ |
| K121235 | LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM | Stryker | 2014-01-09 | Traditional | PDF ↗ |
| K132519 | STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT | Stryker | 2013-12-06 | Traditional | PDF ↗ |
| K132600 | FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING | Biomet Microfixation | 2013-10-02 | Special | PDF ↗ |
| K131289 | I-GEN | Megagen Implant Co., Ltd. | 2013-09-25 | Traditional | PDF ↗ |
| K130840 | SMARTBUILDER SYSTEM (SB1) | Osstem Implant Co., Ltd. | 2013-09-18 | Traditional | PDF ↗ |
| K131674 | PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING | Biomet Microfixation | 2013-08-08 | Special | PDF ↗ |
| K123786 | STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM | Stryker | 2013-04-09 | Traditional | PDF ↗ |
| K122647 | SYNTHES PATIENT SPECIFIC PLATE | Synthes, Inc. | 2013-02-28 | Traditional | PDF ↗ |
| K122890 | INION CPS ORBITAL PLATES | Inion OY | 2013-01-29 | Traditional | PDF ↗ |
| K113567 | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM | Synthes, Inc. | 2012-11-19 | Traditional | PDF ↗ |
| K122313 | STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM | Stryker | 2012-10-31 | Traditional | PDF ↗ |
| K120951 | SMARTBUILDER SYSTEM | Osstem Implant Co., Ltd. | 2012-10-03 | Traditional | PDF ↗ |
| K121589 | BIOMET MICROFIXATION FACIAL PLATING SYSTEM | Biomet Microfixation | 2012-09-21 | Special | PDF ↗ |
| K113512 | BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM | Biomet Microfixation | 2012-06-29 | Special | PDF ↗ |
| K121574 | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM | Synthes, Inc. | 2012-06-29 | Special | PDF ↗ |
| K120271 | ARTISAN SPACE MAINTENANCE SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2012-05-30 | Traditional | PDF ↗ |
| K112457 | LEFORTE SYSTEM BONE PLATE & SCREW | Arkin Consulting Group | 2012-05-18 | Special | PDF ↗ |
| K112064 | RESORB X-G | KLS-Martin L.P. | 2012-03-23 | Traditional | PDF ↗ |
| K111761 | NEO TITANIUM MESH, CTI-MEM | Neobiotech Co., Ltd. | 2012-01-10 | Traditional | PDF ↗ |
| K113251 | SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES | Synthes, Inc. | 2011-12-21 | Special | PDF ↗ |
| K110926 | BONE PLATE; BONE SCREW | Biomaterials Korea, Inc. | 2011-12-08 | Traditional | PDF ↗ |
| K110259 | ARCHITEX SPACE MAINTENANCE SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2011-04-13 | Traditional | PDF ↗ |
| K103136 | SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE | Materialise NV | 2011-03-18 | Traditional | PDF ↗ |
| K103778 | LEFORTE NEURO SYSTEM BONE PLATE | Jeil Medical Corporation | 2011-01-26 | Special | PDF ↗ |
| K102656 | SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM | Synthes (Usa) | 2010-12-20 | Traditional | PDF ↗ |
| K102641 | MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE | Neoortho Produtos Ortopedicos S/A | 2010-12-20 | Traditional | PDF ↗ |
| K100779 | SUSTAIN SPACE MAINTENANCE SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2010-12-13 | Traditional | PDF ↗ |
| K091807 | MEDPOR FIXATION SYSTEM | Porex Surgical, Inc. | 2010-06-28 | Traditional | PDF ↗ |
| K091812 | FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS | Frontier Devices, Inc. | 2010-05-07 | Traditional | PDF ↗ |
| K092743 | THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM | Stryker Craniomaxillofacial | 2010-01-15 | Traditional | PDF ↗ |
| K091233 | SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES | Synthes (Usa) | 2009-12-11 | Traditional | PDF ↗ |
| K091679 | LEFORTE SYSTEM BONE PLATE | Jeil Medical Corporation | 2009-10-02 | Traditional | PDF ↗ |
| K091144 | SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES | Synthes (Usa) | 2009-08-25 | Traditional | PDF ↗ |
| K083388 | SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM | Synthes (Usa) | 2009-03-12 | Traditional | PDF ↗ |
| K082335 | SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM | Synthes (Usa) | 2008-11-10 | Traditional | PDF ↗ |
| K073307 | MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM | Bio-Technology USA, Inc. | 2008-10-29 | Traditional | PDF ↗ |
| K082757 | MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM | Bioplate, Inc. | 2008-10-01 | Special | PDF ↗ |
| K080862 | SONICWELD RX (RESORB-X) | KLS-Martin L.P. | 2008-07-21 | Traditional | PDF ↗ |
| K080694 | OSTEOMED MODULAR LOCKING FIXATION SYSTEM | Osteomed LP | 2008-05-15 | Traditional | PDF ↗ |
| K081067 | FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) | Biomet Microfixation, Inc. | 2008-05-09 | Special | PDF ↗ |
| K080331 | SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM | Synthes (Usa) | 2008-04-30 | Traditional | PDF ↗ |
| K072528 | ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES | Prosurg, Inc. | 2007-12-28 | Traditional | PDF ↗ |
Product code JEY · Class II · Dental. Data: openFDA.