| CraniUS Plate (K261058) | CraniUS, LLC | 2026-07-29 |
| TECHFIT Patient-Specific Cranial System (K250297) | Techfit Digital Surgery, Inc. | 2025-10-27 |
| Fusion Craniofacial Implant; Fusion Skull Implant (K250334) | Kelyniam Global, Inc. | 2025-07-25 |
| VSP PEEK Cranial Implant (K231834) | 3D Systems, Inc. | 2024-04-04 |
| MCI-Neuro Fixation System (K212391) | Mci Medical Concept Innovation, Inc. | 2022-10-21 |
| Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models) (K210360) | Osteonic Co., Ltd. | 2022-01-27 |
| Stryker PEEK Customized Cranial Implant Kit (K203055) | Stryker | 2021-02-09 |
| Optimus NEURO System - Sterile Kit (K190811) | Osteonic Co., Ltd. | 2019-11-27 |
| Stryker PEEK Customized Cranial Implant Kit (K190229) | Stryker | 2019-07-11 |
| Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) (K182711) | Kelyniam Global, Inc. | 2019-05-21 |
| Optimus Neuro System (K183352) | Osteonic Co., Ltd. | 2019-01-02 |
| Universal Mesh - Sterile (K182425) | Stryker Leibinger GmbH & Co KG | 2018-11-06 |
| Stryker Universal Mesh (K170725) | Stryker | 2017-11-13 |
| Sterile NS System (K170368) | Jeil Medical Corporation | 2017-09-11 |
| Stryker Universal Mesh (K161821) | Stryker | 2016-12-08 |
| Biopor Porous Polyethylene Implants (K161446) | Ceremed , Inc. | 2016-09-27 |
| PEEK Customized Cranial Implant (K153248) | Stryker | 2016-03-10 |
| PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority (K152076) | Stryker | 2015-08-26 |
| ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM (K141123) | Alliance Partners, LLC | 2015-02-27 |
| OPTIMUS NEURO SYSTEM (K141911) | Osteonic Co., Ltd. | 2015-02-10 |
| INNOVASIS CRANIAL SYSTEM (K141644) | Innovasis, Inc. | 2014-11-07 |
| LEFORTE NEURO SYSTEM BONE PLATE AND SCREW (K141452) | Jeil Medical Corporation | 2014-07-02 |
| MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM) (K140462) | Synthes (USA) Products, LLC | 2014-06-13 |
| UNIVERSAL NEURO 3 SYSTEM (K131775) | Stryker | 2013-10-17 |
| SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM (K123723) | Synthes | 2013-09-05 |
| NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM (K122049) | Kinamed, Inc. | 2013-04-05 |
| RESORB-X G (K121606) | KLS-Martin L.P. | 2013-01-17 |
| BIOMET MICROFIXATION NEURO PLATING SYSTEM (K121624) | Biomet Microfixation | 2012-10-12 |
| PEEK CUSTOMIZED CRAIAL IMPLANT KIT (K121153) | Stryker | 2012-09-14 |
| STRYKER QUIKFLAP STERILE PROCEDURE PACK (K120352) | Stryker | 2012-06-11 |
| LEFORTE NEURO SYSTEM BONE PLATE (K112812) | Jeil Medical Corporation | 2012-02-22 |
| STRYKER UNIVERSAL NEURO 3 SYSTEM (K112557) | Stryker | 2012-01-05 |
| OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM (K111176) | Osteomed LP | 2011-08-15 |
| STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT (K111065) | Howmedica Osteonics Corp. Dba Stryker Orthopeadics | 2011-07-14 |
| FRONTIER DEVICES NEURO SYSTEM (K100205) | Folsom Metal Products, Inc. | 2010-12-13 |
| OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM (K073006) | Takiron Co., Ltd. | 2008-05-29 |
| SYNTHES (USA) 2.0MM TITANIUM T-PLATE (K072758) | Synthes (Usa) | 2007-12-18 |
| SYNTHES CRANIAL SPRING CLIP (CSC) (K974206) | Synthes (Usa) | 1998-03-16 |
| TITANIUM MESH (K903485) | Ruggles Corp. | 1991-02-21 |
| NEUROSCOPE SEEG (K861884) | Siegen Corp. | 1986-10-14 |
| MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI (K861822) | Valley Forge Scientific Corp. | 1986-07-11 |
| RION AUDIOMETER AA-67 (K812951) | Rion Acoustic Instruments, Inc. | 1981-11-06 |
| RION AUDIOMETER AA-68 (K812952) | Rion Acoustic Instruments, Inc. | 1981-11-06 |