TiLink-L SI Joint Fusion System— 510(k) K261381

Name: FDA 510(k) clearance K261381
Creator: U.S. Food and Drug Administration
Published: 2026-08-24

Substantially Equivalent

SurGenTec, LLC

FDA 510(k) clearance K261381 for TiLink-L SI Joint Fusion System, Substantially Equivalent on 2026-08-24. Applicant: SurGenTec, LLC. Device class: 2.

Clearance details

Applicant: SurGenTec, LLC
Product code: Code OUR
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2026-04-27
Decision date: 2026-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OUR

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K260477 — CATAMARAN SI Joint Fusion System2026-04-08
K253488 — iFuse INTRA Ti Implant System2026-02-11
K253611 — Falco Fusion System2026-01-29
K252834 — Sacroiliac Joint Truss System (SJTS)2026-01-28
K251365 — OptumSI Implant System2025-11-20

More clearances from SurGenTec, LLC

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K262581 — GraftGun Universal Graft Delivery System (GDS®)2026-08-26
K262121 — Ion-L Navigated Instruments2026-07-24
K261209 — Ion-L2026-06-11
K260329 — Ion-C Navigation Instruments2026-05-22
K253604 — TiLink-L Navigation Instruments2026-03-20

Adverse events under product code OUR

product code OUR

Death: 3
Injury: 347
Total: 350

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.