The following data is part of a premarket notification filed by Bodycad Laboratories, Inc. with the FDA for Bodycad Unicompartmental Knee System.
| Device ID | K191150 |
| 510k Number | K191150 |
| Device Name: | Bodycad Unicompartmental 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 | 2019-05-01 |
| Decision Date | 2019-10-08 |