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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K193614
Device Name FINE Osteotomy around the knee
Applicant
Bodycad Laboratories, Inc.
2035 Rue Du Haut-Bord
Quebec City,  CA G1n 4R7
Applicant Contact Guy Sevigny
Correspondent
BioVera, Inc.
65 Promenade Saint Louis
Notre-Dame-De-Llle-Perrot,  CA J7V7P2
Correspondent Contact Robert A Poggie
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   PBF  
Date Received12/26/2019
Decision Date 03/25/2020
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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