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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 K253538
Device Name TeKBrace Knotless Anchor
Applicant
Theramicro
51 Germantown Court
Suite 200
Cordova,  TN  38018
Applicant Contact Christine Scifert
Correspondent
Theramicro
51 Germantown Court
Suite 200
Cordova,  TN  38018
Correspondent Contact Christine Scifert
Regulation Number888.3040
Classification Product Code
MBI  
Date Received11/13/2025
Decision Date 03/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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