510(k) K241435
Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue by
Smith & Nephew, Inc.
— Product Code MBI
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 2024
- Date Received
- May 21, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Nondegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type