510(k) K231831
K231831 is an FDA 510(k) premarket notification submitted by Surgentec for the device "TiLink-L Joint Fusion System". The FDA issued a decision of Substantially Equivalent on Aug 3, 2023. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Surgentec has 31 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 3, 2023
- Date Received
- Jun 22, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sacroiliac Joint Fixation
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)
sacroiliac joint fusion