TiLink-P SI Joint Fusion System— 510(k) K230857

Substantially Equivalent

SurGenTec, LLC

FDA 510(k) clearance K230857 for TiLink-P SI Joint Fusion System, Substantially Equivalent on 2023-09-25. Applicant: SurGenTec, LLC.

Clearance details

Applicant: SurGenTec, LLC
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2023-03-29
Decision date: 2023-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

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.