| K250297 | TECHFIT Patient-Specific Cranial System | Techfit Digital Surgery, Inc. | 2025-10-27 |
| K250334 | Fusion Craniofacial Implant; Fusion Skull Implant | Kelyniam Global, Inc. | 2025-07-25 |
| K231834 | VSP PEEK Cranial Implant | 3D Systems, Inc. | 2024-04-04 |
| K212391 | MCI-Neuro Fixation System | Mci Medical Concept Innovation, Inc. | 2022-10-21 |
| K210360 | 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) | Osteonic Co., Ltd. | 2022-01-27 |
| K190811 | Optimus NEURO System - Sterile Kit | Osteonic Co., Ltd. | 2019-11-27 |
| K190229 | Stryker PEEK Customized Cranial Implant Kit | Stryker | 2019-07-11 |
| K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | Kelyniam Global, Inc. | 2019-05-21 |
| K183352 | Optimus Neuro System | Osteonic Co., Ltd. | 2019-01-02 |
| K182425 | Universal Mesh - Sterile | Stryker Leibinger GmbH & Co KG | 2018-11-06 |
| K170725 | Stryker Universal Mesh | Stryker | 2017-11-13 |
| K170368 | Sterile NS System | Jeil Medical Corporation | 2017-09-11 |
| K161821 | Stryker Universal Mesh | Stryker | 2016-12-08 |
| K161446 | Biopor Porous Polyethylene Implants | Ceremed , Inc. | 2016-09-27 |
| K153248 | PEEK Customized Cranial Implant | Stryker | 2016-03-10 |