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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 K232457
Device Name Q-FIX ULTRA All-Suture Anchor
Applicant
Smith & Nephew
150 Minuteman Rd.
Andover,  MA  01810
Applicant Contact Catherine Phelan
Correspondent
Smith & Nephew
150 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact Catherine Phelan
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Codes
GAT   HTW  
Date Received08/14/2023
Decision Date 09/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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