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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Implantable
510(k) Number K263461
Device Name Tendon Anchor
Applicant
Smith & Nephew, Inc.
150 Minuteman Rd.
Andover,  MA  01810
Applicant Contact Amanda Cole
Correspondent
Smith & Nephew, Inc.
150 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact Amanda Cole
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
HXJ  
Date Received09/28/2026
Decision Date 10/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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