Cleared Special

Q-FIX ULTRA All-Suture Anchor

K232457 · Smith & Nephew · Orthopedic
Sep 2023
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K232457 is an FDA 510(k) clearance for the Q-FIX ULTRA All-Suture Anchor, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Smith & Nephew (Andover, US). The FDA issued a Cleared decision on September 8, 2023, 25 days after receiving the submission on August 14, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K232457 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2023
Decision Date September 08, 2023
Days to Decision 25 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040