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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, Biodegradable, Soft Tissue
510(k) Number K252946
Device Name BioBrace® Extra-Articular Ligament Augmentation Kit
Applicant
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Applicant Contact Amy DeLong
Correspondent
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Correspondent Contact Amy DeLong
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Codes
OWW   OWY  
Date Received09/15/2025
Decision Date 10/15/2025
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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