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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 K261968
Device Name Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)
Applicant
Smith & Nephew, Inc.
150 Minuteman Rd.
Andover,  MA  01810
Applicant Contact Xianjun Chen
Correspondent
Smith & Nephew, Inc.
150 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact Xianjun Chen
Regulation Number888.3040
Classification Product Code
MBI  
Date Received06/11/2026
Decision Date 07/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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