BC Reflex Uni Knee System

Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

Bodycad Laboratories, Inc.

The following data is part of a premarket notification filed by Bodycad Laboratories, Inc. with the FDA for Bc Reflex Uni Knee System.

Pre-market Notification Details

Device IDK211895
510k NumberK211895
Device Name:BC Reflex Uni Knee System
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant Bodycad Laboratories, Inc. 2035, Rue Du Haut-Bord Quebec City,  CA G1n 4r7
ContactNadine Adia
CorrespondentRobert A Poggie
BioVera, Inc. 65 Promenade Saint Louis Notre Dame De L'lle Perrot,  CA J7v 7p2
Product CodeHSX  
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-21
Decision Date2021-08-20

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