510(k) K230446
K230446 is an FDA 510(k) premarket notification submitted by SurGenTec, LLC for the device "TiLink-L SI Joint Fusion System". The FDA issued a decision of Substantially Equivalent on Jun 7, 2023. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. SurGenTec, LLC has 31 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 7, 2023
- Date Received
- Feb 21, 2023
- Clearance Type
- Traditional
- 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