The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Comprehensive Vault Reconstruction System (vrs).
| Device ID | K152754 |
| 510k Number | K152754 |
| Device Name: | COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | BIOMET MANUFACTURING CORP. 56 BELL DRIVE Warsaw, IN 46580 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET MANUFACTURING CORP. 56 BELL DRIVE Warsaw, IN 46580 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-24 |
| Decision Date | 2016-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304834026 | K152754 | 000 |
| 00880304818965 | K152754 | 000 |
| 00889024563599 | K152754 | 000 |
| 00880304818934 | K152754 | 000 |
| 00880304818941 | K152754 | 000 |
| 00880304826526 | K152754 | 000 |
| 00880304829473 | K152754 | 000 |
| 00880304829480 | K152754 | 000 |
| 00880304829497 | K152754 | 000 |
| 00880304829503 | K152754 | 000 |
| 00880304829510 | K152754 | 000 |
| 00880304829527 | K152754 | 000 |
| 00880304818958 | K152754 | 000 |