K261968
- 510(k) number
- K261968
- Device name
- Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)
- Applicant
- Smith & Nephew, Inc. MA · US
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2026-07-09
- Date received
- 2026-06-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K261968.pdf
Official FDA record: K261968
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.