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

510(k) number
K241435
Device name
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
Applicant
Smith & Nephew, Inc. MA · US
Product code
MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Decision date
2024-06-20
Date received
2024-05-21
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain

Also available from FDA: K241435.pdf

Official FDA record: K241435
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.