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SurGenTec

HQ: Boca Raton, FL source · surgentec.com ↗ · Southeast

FDA-cleared device company

Location: Boca Raton, FL · source · Oct 15, 2026

Profile checked Oct 10, 2026

16FDA records (2 yrs)

Timeline

  1. FDA FDA 510(k) clearance: Durashield Device Kit — K252995, Sep 17, 2026. Applicant at approval: SurGenTec, LLC. source ↗
  2. FDA FDA 510(k) clearance: GraftGun Universal Graft Delivery System (GDS®) — K262581, Aug 26, 2026. Applicant at approval: SurGenTec, LLC. source ↗
  3. FDA FDA 510(k) clearance: TiLink-L™ SI Joint Fusion System — K261381, Aug 24, 2026. Applicant at approval: SurGenTec, LLC. source ↗
  4. FDA FDA 510(k) clearance: Ion-L Navigated Instruments — K262121, Jul 24, 2026. Applicant at approval: SurGenTec, LLC. source ↗
  5. FDA FDA 510(k) clearance: Ion-L — K261209, Jun 11, 2026. Applicant at approval: SurGenTec, LLC. source ↗
  6. FDA FDA 510(k) clearance: Ion-C Navigation Instruments — K260329, May 22, 2026. Applicant at approval: SurGenTec, LLC. source ↗
  7. FDA FDA 510(k) clearance: TiLink-L Navigation Instruments — K253604, Mar 20, 2026. Applicant at approval: SurGenTec, LLC. source ↗
  8. FDA FDA 510(k) clearance: Ion-C — K251714, Jan 16, 2026. Applicant at approval: SurGenTec, LLC. source ↗
  9. FDA FDA 510(k) clearance: OsteoFlo HydroFiber — K251720, Jul 2, 2025. Applicant at approval: SurGenTec, LLC. source ↗
  10. FDA FDA 510(k) clearance: OsteoFlo HydroFiber — K243949, May 28, 2025. Applicant at approval: SurGenTec, LLC. source ↗
  11. FDA FDA 510(k) clearance: ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) — K243945, Apr 24, 2025. Applicant at approval: SurGenTec, LLC. source ↗
  12. FDA FDA 510(k) clearance: GraftGun Universal Graft Delivery System (GDS) — K243580, Feb 5, 2025. Applicant at approval: SurGenTec, LLC. source ↗
  13. FDA FDA 510(k) clearance: TiLink-P SI Joint Fusion System — K243835, Dec 27, 2024. Applicant at approval: SurGenTec, LLC. source ↗
  14. FDA FDA 510(k) clearance: OsteoFlo HydroFiber — K242797, Dec 23, 2024. Applicant at approval: SurGenTec, LLC. source ↗
  15. FDA FDA 510(k) clearance: Ion 3D — K243265, Dec 4, 2024. Applicant at approval: SurGenTec, LLC. source ↗
  16. FDA FDA 510(k) clearance: TiLink-P Joint Fusion System — K242414, Nov 21, 2024. Applicant at approval: SurGenTec, LLC. source ↗

FDA records (last 2 years)

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