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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, Absorbable, Orthopaedics, Reinforcement Of Tendon
510(k) Number K203267
Device Name The BioBrace Implant
Applicant
Biorez, Inc.
470 James St., Suite 14
New Haven,  CT  06513
Applicant Contact Kevin Rocco
Correspondent
BioVera, Inc.
65 Promenade Saint Louis
Notre-Dame-De-L'Ile Perrot,  CA J7V 7P2
Correspondent Contact Robert A Poggie
Regulation Number878.3300
Classification Product Code
OWW  
Subsequent Product Code
OWY  
Date Received11/05/2020
Decision Date 04/30/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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