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 |
|---|---|---|---|
| Aug 17, 2026 | K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Soluti KLS-Martin L.P. | JEY |
| Jul 25, 2026 | K253206 | METICULY Patient-specific CMF solution Meticuly Co., Ltd., TH | JEY |
| Apr 2, 2026 | K252246 | Leforte MMF System Jeil Medical Corporation, KR | JEY |
| Dec 19, 2025 | K253373 | Southern Craniomaxillofacial (CMF) System Southern Medical (Pty) , Ltd., ZA | JEY |
| Nov 7, 2025 | K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System Inion OY, FI | JEY |
| Aug 16, 2024 | K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) KLS-Martin L.P. | JEY |
| Jul 12, 2024 | K240651 | MRI Universal Stryker Leibinger GmbH & Co KG, DE | JEY |
| Jul 11, 2024 | K233874 | tmCMF Solution Techmah Cmf | JEY |
| Apr 30, 2024 | K232889 | METICULY Patient-specific titanium maxillofacial mesh implant Meticuly Co., Ltd., TH | JEY |
| Jan 13, 2024 | K232350 | Stryker Facial iD System Stryker Craniomaxillofacial | JEY |
| Sep 26, 2023 | K230398 | MedCAD® AccuPlate® 3DTi Patient-Specific Plating System Medcad | JEY |
| Aug 5, 2023 | K230733 | Stryker Resorbable Fixation System Stryker Leibinger GmbH & Co KG, DE | JEY |
| Dec 9, 2022 | K222650 | Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate Stryker Craniomaxillofacial (Cmf) | JEY |
| Nov 10, 2022 | K220360 | Tandry CMF Plate System Microware Precision Co., Ltd., TW | JEY |
| Nov 9, 2022 | K221855 | Universal CMF System Stryker Leibinger GmbH & Co KG, DE | JEY |
| Jul 18, 2022 | K210731 | KLS Martin Individual Patient Solutions KLS-Martin L.P. | JEY |
| Feb 4, 2022 | K213777 | Stryker Resorbable Fixation System Stryker Leibinger Micro Implants | JEY |
| Aug 5, 2021 | K202969 | Biomet Microfixation OmniMax MMF System Biomet Microfixation | JEY |
| Jul 14, 2021 | K202918 | OsteoSync Ti Dental Mesh Sites Medical, LLC | JEY |
| May 19, 2021 | K203282 | TECHFIT Patient-Specific Maxillofacial System Industrias Medicas Sampedro S.A.S, CO | JEY |
| Feb 12, 2021 | K193280 | MedCAD® AccuPlate® Patient-Specific Plate Medcad | JEY |
| Sep 10, 2020 | K201944 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) Synthes (USA) Products, LLC | JEY |
| Jul 29, 2020 | K182759 | BoniPlus Dental G-Mesh System Montjade Engineering Co., Ltd., TW | JEY |
| Jun 17, 2020 | K192747 | Yxoss CBR® Reoss GmbH, DE | JEY |
| Apr 22, 2020 | K191997 | FAICO CMF System Faico Medical, LLC | JEY |
| Mar 26, 2020 | K193143 | Stryker Facial iD Plating System Stryker | JEY |
| Mar 26, 2020 | K193136 | Stryker Customized Mandible Recon Plate Kit Stryker | JEY |
| Dec 30, 2019 | K192655 | Depuy Synthes Maxillofacial Portfolio - MR Conditional Synthes (USA) Products, LLC | JEY |
| Dec 5, 2019 | K182758 | MCI - CMF System Mci Medical Concept Innovation, Inc. | JEY |
| Nov 22, 2019 | K191028 | KLS Martin Individual Patient Solutions KLS-Martin L.P. | JEY |
| Jun 28, 2019 | K190696 | Stryker Surgeon iD Mandible Recon Plate Stryker | JEY |
| Mar 29, 2019 | K182609 | Delphos Implants Rigid Fixation System Delphos Implants - Ind.Com. Importacao E Exportacao DE, PT | JEY |
| Jan 7, 2019 | K182305 | Stryker Facial iD Plating System Stryker | JEY |
| Dec 28, 2018 | K180204 | CranioMaxillofacial Fixation (CMF) System - CMF Visionare Visionare, LLC | JEY |
| Oct 11, 2018 | K180249 | OmniPore DUROMAX Surgical Implants Matrix Surgical Holdings, LLC/Matrix Surgical USA | JEY |
| Aug 13, 2018 | K180962 | KLS Martin Individual Patient Solutions KLS-Martin L.P. | JEY |
| Jul 10, 2018 | K173039 | TruMatch CMF Titanium 3D Printed Implant Materialise NV, BE | JEY |
| May 24, 2018 | K170697 | GBR system Surgident, KR | JEY |
| Mar 26, 2018 | K172354 | OssBuilder System Osstem Implant Co., Ltd., KR | JEY |
| Feb 23, 2018 | K173320 | KLS Martin L1 MMF System KLS Martin L.P. | JEY |
| Nov 21, 2017 | K163579 | KLS Martin Individual Patient Solutions KLS Martin L.P. | JEY |
| Nov 8, 2017 | K170773 | Stryker Universal Mesh Stryker | JEY |
| Oct 31, 2017 | K172572 | Stryker Upper-Face AXS screws and Mid-Face AXS screws Stryker | JEY |
| Aug 8, 2017 | K170272 | TruMatch CMF Titanium 3D Printed Implant System Materialise NV, BE | JEY |
| Jul 24, 2017 | K171364 | MP LeFort I Plates Stryker | JEY |
| Oct 20, 2016 | K160363 | OPTIMUS CMF SYSTEM Osteonic Co., Ltd., KR | JEY |
| Dec 10, 2015 | K152326 | Biomet Microfixation OmniMax MMF System Biomet Microfixation | JEY |
| Sep 17, 2015 | K150965 | LeForte System II Jeil Medical Corporation, KR | JEY |
| Jun 10, 2015 | K143730 | GBR System Jeil Medical Corporation, KR | JEY |
| May 5, 2015 | K142568 | Stryker MEDPOR TITAN 3D Orbital Floor Implant Stryker | JEY |
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