| Ion-L Navigated Instruments (K262121) | SurGenTec, LLC | 2026-07-24 |
| Ion-L (K261209) | SurGenTec, LLC | 2026-06-11 |
| Ion-C Navigation Instruments (K260329) | SurGenTec, LLC | 2026-05-22 |
| TiLink-L Navigation Instruments (K253604) | SurGenTec, LLC | 2026-03-20 |
| Ion-C (K251714) | SurGenTec, LLC | 2026-01-16 |
| OsteoFlo HydroFiber (K251720) | SurGenTec, LLC | 2025-07-02 |
| OsteoFlo HydroFiber (K243949) | SurGenTec, LLC | 2025-05-28 |
| ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (K243945) | SurGenTec, LLC | 2025-04-24 |
| GraftGun Universal Graft Delivery System (GDS) (K243580) | SurGenTec, LLC | 2025-02-05 |
| TiLink-P SI Joint Fusion System (K243835) | SurGenTec, LLC | 2024-12-27 |
| OsteoFlo HydroFiber (K242797) | SurGenTec, LLC | 2024-12-23 |
| Ion 3D (K243265) | SurGenTec, LLC | 2024-12-04 |
| TiLink-P Joint Fusion System (K242414) | SurGenTec, LLC | 2024-11-21 |
| TiLink-P SI Joint Fusion System (K242141) | SurGenTec, LLC | 2024-08-21 |
| ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (K240664) | SurGenTec, LLC | 2024-08-09 |
| Ion 3D (K241416) | SurGenTec, LLC | 2024-06-17 |
| TiLink-P SI Joint Fusion System (K240720) | SurGenTec, LLC | 2024-04-11 |
| Ion 3D (K240086) | SurGenTec, LLC | 2024-02-08 |
| OsteoFlo® HydroPutty™ (K231716) | SurGenTec, LLC | 2023-10-02 |
| TiLink-P SI Joint Fusion System (K230857) | SurGenTec, LLC | 2023-09-25 |
| TiLink-L SI Joint Fusion System (K230446) | SurGenTec, LLC | 2023-06-07 |
| Ion Facet Screw System (K211855) | SurGenTec, LLC | 2022-02-25 |
| OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft (K200064) | SurGenTec, LLC | 2020-08-14 |
| ALARA Neuro Access Kit (K190163) | SurGenTec, LLC | 2019-07-16 |
| Graftgun Universal Graft Delivery System (K180937) | SurGenTec, LLC | 2018-05-10 |
| Graftgun Universal Graft Delivery System (K170675) | SurGenTec, LLC | 2017-07-19 |