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 | K211895 |
| 510k Number | K211895 |
| 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 | 2021-06-21 |
| Decision Date | 2021-08-20 |