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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name fastener, fixation, nondegradable, soft tissue
510(k) Number K231376
Device Name Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)
Smith & Nephew Inc.
150 Minuteman Road
Andover,  MA  01810
Applicant Contact Pragnya Bakka
Smith & Nephew Inc.
150 Minuteman Road
Andover,  MA  01810
Correspondent Contact Pragnya Bakka
Regulation Number888.3040
Classification Product Code
Date Received05/12/2023
Decision Date 08/09/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No