510(k) clearance
TiLink-L™ SI Joint Fusion System
- 510(k) number
- K261381
- Applicant
- SurGenTec, LLC
- Decision date
- Aug 24, 2026
- Date received
- Apr 27, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OUR
- Device type
- Sacroiliac Joint Fixation
- Device class
- Class II
- Regulation
- 21 CFR 888.3040
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Boca Raton, FL, US