BC Reflex Uni Knee System

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

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

Device ID	K212307
510k Number	K212307
Device Name:	BC Reflex Uni Knee System
Classification	Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant	Bodycad Laboratories, Inc. 2035, Rue Du Haut-Bord Quebec City, CA G1n 4r7
Contact	Nadine Adia
Correspondent	Robert A Poggie BioVera, Inc. 65 Promenade Saint Louis Notre Dame De L'lle Perrot, CA J7v 7p2
Product Code	HSX
CFR Regulation Number	888.3520 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	2021-07-23
Decision Date	2021-10-12
Summary:	summary