510(k) clearance
Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one Black knotless and one Blue MINITAPE Suture; Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one Blue knotless and one Black MINIT
- 510(k) number
- K263348
- Applicant
- Smith & Nephew, Inc.
- Decision date
- Oct 23, 2026
- Date received
- Sep 23, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- MBI
- Device type
- Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II
- Regulation
- 21 CFR 888.3040
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Andover, MA, US