The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Comprehensive Vault Reconstruction System.
| Device ID | K202232 |
| 510k Number | K202232 |
| Device Name: | Comprehensive Vault Reconstruction System |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | Biomet Manufacturing Corp. 56 E. Bell Drive Warsaw, IN 46582 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres Biomet Manufacturing Corp. 56 E. Bell Drive Warsaw, IN 46582 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-07 |
| Decision Date | 2021-02-19 |