TiLink-L SI Joint Fusion System— 510(k) K261381
Substantially EquivalentSurGenTec, 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.
Summary
SurGenTec filed the TiLink-L SI Joint Fusion System under product code OUR, sacroiliac joint fixation. The record gives no model numbers or further description.
Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel. The submission was a Traditional 510(k).
SurGenTec filed from Boca Raton, Florida. The substantially equivalent decision came 119 calendar days after receipt (April 27 to August 24, 2026).
Clearance details
- Applicant
- SurGenTec, LLC
- Product code
- Product code OUR
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boca Raton, FL, US
Recent devices under product code OUR
view allMore clearances from SurGenTec, LLC
view allAdverse events under product code OUR
product code OUR- Death
- 3
- Injury
- 347
- Total
- 350
Source: openFDA MAUDE database, through . 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.