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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K211895
Device Name BC Reflex Uni Knee System
Applicant
Bodycad Laboratories, Inc.
2035 Rue Du Haut-Bord
Quebec,  CA G1N 4R7
Applicant Contact Nadine Adia
Correspondent
BioVera, Inc.
65 Promenade Saint Louis
Notre-Dame-De-Llle-Perrot,  CA J7V7P2
Correspondent Contact Robert A Poggie
Regulation Number888.3520
Classification Product Code
HSX  
Date Received06/21/2021
Decision Date 08/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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