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 | K191996 |
| 510k Number | K191996 |
| 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 | Guy Sevigny |
| Correspondent | Robert A. Poggie BioVera Inc. 65 Promenade Saint Louis Notre-dame-de-l'ile-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 | 2019-07-26 |
| Decision Date | 2019-12-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 62845195000066 | K191996 | 000 |
| 00688346000061 | K191996 | 000 |
| 00688346002072 | K191996 | 000 |