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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
510(k) Number K261621
Device Name TekBrace Solo Soft Tissue Reinforcement Device
Applicant
Theramicro
51 Germantown Ct.
Suite 200
Cordova,  TN  38018
Applicant Contact Christine Scifert
Correspondent
Theramicro
51 Germantown Ct.
Suite 200
Cordova,  TN  38018
Correspondent Contact Christine Scifert
Regulation Number878.3300
Classification Product Code
QUW  
Subsequent Product Codes
FTL   OWX  
Date Received05/15/2026
Decision Date 06/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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