Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K253604
TiLink-L Navigation Instruments · SurGenTec, LLC · decided 2026-03-20 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| TiLink-L Navigation Inserter Hexalobe Driver | SR21-6304 | Surgentec, LLC | OLO | 00810131882563 |
| TiLink-L Navigation Drill Guide | SR21-6301 | Surgentec, LLC | OLO | 00810131882556 |
| TiLink-L Navigation Impact Cap | SR21-6303 | Surgentec, LLC | OLO | 00810131882617 |
| TiLink-L Navigation Drill Bit - 8mm | SR21-6305 | Surgentec, LLC | OLO | 00810131882532 |