Bodycad Unicompartmental 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 Bodycad Unicompartmental Knee System.

Pre-market Notification Details

Device IDK191150
510k NumberK191150
Device Name:Bodycad Unicompartmental Knee System
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant Bodycad Laboratories, Inc. 2035, Rue Du Haut-Bord Quebec City,  CA G1n 4r7
ContactGuy Sevigny
CorrespondentRobert A Poggie
BioVera Inc. 65 Promenade Saint Louis Notre-dame-de-l'ile-perrot,  CA J7v 7p2
Product CodeHSX  
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-01
Decision Date2019-10-08

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