510(k) K231787
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 2023
- Date Received
- June 20, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Biodegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type