Cleared Traditional

Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)

K231376 · Smith & Nephew, Inc. · Orthopedic
Aug 2023
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K231376 is an FDA 510(k) clearance for the Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape), a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on August 9, 2023, 89 days after receiving the submission on May 12, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K231376 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2023
Decision Date August 09, 2023
Days to Decision 89 days
Submission Type Traditional
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

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