| ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754) (K260709) | Longeviti Neuro Solutions | 2026-06-25 |
| 3D MAC Titanium Cranial Plate (TCP) System (K253116) | The Surgeon General, Department of the Army (TSG-DA) | 2026-06-18 |
| EASYMADE-TI (K252251) | CG Bio Co., Ltd. | 2026-04-09 |
| METICULY Patient-specific titanium mesh implant (K252958) | Meticuly Co., Ltd. | 2026-01-14 |
| Synthes Patient Specific Implants (K243715) | Synthes GmbH | 2025-11-12 |
| KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE (K252573) | KLS-Martin L.P. | 2025-11-10 |
| CustomizedBone Service (K240567) | Fin-Ceramica Faenza S.P.A. | 2024-03-28 |
| Longeviti ClearFit OTS Cranial Implant (K231920) | Longeviti Neuro Solutions, LLC | 2023-11-09 |
| PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) (K214109) | Kontour(Xi’An) Medical Technology Co., Ltd. | 2022-10-28 |
| MedCAD AccuShape Titanium Patient-Specific Cranial Implant (K220357) | Medcad | 2022-08-26 |
| Meticuly Patient-Specific Titanium Mesh Implant (K210099) | Meticuly Co., Ltd. | 2021-12-21 |
| Longeviti ClearFit™ OTS Cranial Implants (K212058) | Longeviti Neuro Solutions, LLC | 2021-09-08 |
| Longeviti PMMA Static Cranial Implant (K210616) | Longeviti Neuro Solutions, LLC | 2021-03-31 |
| Longeviti ClearFit Cranial Implant (K203349) | Longeviti Neuro Solutions, LLC | 2020-12-16 |
| Longeviti ClearFit Cranial Implant (K202901) | Longeviti Neuro Solutions, LLC | 2020-10-30 |
| DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional (K192702) | Synthes (USA) Products, LLC | 2020-09-18 |
| CustomizedBone Service (K193547) | Fin-Ceramica Faenza S.P.A. | 2020-01-17 |
| Longeviti ClearFit Cranial Implant (K191210) | Longeviti Neuro Solutions, LLC | 2020-01-09 |
| OsteoFab Patient Specific Cranial Device (K180064) | Oxford Performance Materials, Inc. | 2018-07-27 |
| CustomizedBone Service (K180513) | Fin-Ceramica Faenza S.P.A. | 2018-05-15 |
| Longeviti PMMA Static Cranial Implant (K170410) | Longeviti Neuro Solutions, LLC | 2018-03-23 |
| CustomizedBone Service (K171507) | Fin-Ceramica Faenza S.P.A. | 2017-09-01 |
| Cranial PSI (K161090) | Ossdsign AB | 2017-01-19 |
| CustomizedBone Service (K160707) | Fin-Ceramica Faenza S.P.A. | 2016-12-17 |
| BioArchitects Patient Specific Cranial/Craniofacial Plate (K151692) | Bioarchitects USA, LLC | 2015-11-20 |
| Patient Contoured Implant-PEEK (PCI-PEEK) (K151382) | KLS Martin L.P. | 2015-11-09 |
| SPEEDY FLAP SYSTEM (K130447) | Jeil Medical Corporation | 2014-12-22 |
| OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE (K133082) | Osteosymbionics, LLC | 2014-05-20 |
| OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE (K121818) | Oxford Performance Materials | 2013-02-07 |
| CUSTOM CRANIOFACIAL IMPLANT (CCI) (K121755) | Kelyniam Global, Inc. | 2012-09-25 |
| CRAINFIX 2 TITANIUM CLAMP SYSTEM (K122353) | Aesculap, Inc. | 2012-08-30 |
| OSTEOSYMBIONICS PEEK CRANIAL IMPLANT (K121102) | Osteosymbionics, LLC | 2012-08-08 |
| MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT (K110684) | Vanduzen Dba Medcad | 2011-06-24 |
| KELYNIAM CUSTOM SKULL IMPLANT (CSI) (K103582) | Kelyniam Global, Inc. | 2011-04-14 |
| MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION (K082175) | Bioplate, Inc. | 2008-08-13 |
| PATIENT CONTOURED MESH-PEEK (PCM-P) (K072707) | KLS-Martin L.P. | 2007-12-19 |
| MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM (K070901) | Bioplate, Inc. | 2007-06-15 |
| BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY (K062819) | Bioplate, Inc. | 2006-12-04 |
| KLS MARTIN QUICK DISC (K062857) | KLS Martin L.P. | 2006-11-22 |
| PATIENT CONTOURED MESH (PCM) (K062570) | KLS-Martin L.P. | 2006-10-31 |
| STRYKER CUSTOM TI IMPLANT (K052871) | Stryker Leibinger | 2005-12-16 |
| SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT (K053199) | Synthes (Usa) | 2005-12-14 |
| SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS (K033868) | Synthes (Usa) | 2004-06-21 |
| CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM (K040864) | Aesculap | 2004-06-17 |
| SPIN DOWN RAPIDFLAP (K031034) | Walter Lorenz Surgical, Inc. | 2003-05-21 |
| OSTEOMED CRANIAL FLAP FIXATION SYSTEM (K022277) | Osteomed Corp. | 2003-04-01 |
| STRYKER LEIBINGER CRANIAL FIXATION SYSTEM (K030378) | Stryker Instruments | 2003-03-20 |
| MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM (K020088) | Bioplate, Inc. | 2002-02-08 |
| THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM (K013050) | Bioplate, Inc. | 2001-12-10 |
| MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520 (K013000) | Medtronic Neurosurgery | 2001-12-05 |
| LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM (K993990) | Stryker Instruments | 2000-02-22 |
| SYNTHES CRANIAL FLAP TUBE CLAMP (K992000) | Synthes (Usa) | 1999-07-20 |
| SYNTHES CRANIAL FLAP TWIST CLAMP (K991860) | Synthes (Usa) | 1999-07-20 |
| RAPIDFLAP CRANIAL CLAMP (K991029) | Walter Lorenz Surgical, Inc. | 1999-04-23 |
| SEVRAIN CRANIAL CLAMP (K971252) | Ikonos Corp. | 1998-07-06 |
| SEVRAIN CRANIAL CLAMP (SCC-200 SERIES) (K971408) | Ikonos Corp. | 1998-05-12 |
| AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM (K972332) | Aesculap, Inc. | 1998-01-16 |