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 IDK203697
510k NumberK203697
Device Name:BC Reflex Uni Knee System
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant Bodycad Laboratories, Inc. 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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-18
Decision Date2021-03-12

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