The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Comprehensive Reverse Shoulder.
| Device ID | K113121 |
| 510k Number | K113121 |
| Device Name: | COMPREHENSIVE REVERSE SHOULDER |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-21 |
| Decision Date | 2011-12-16 |
| Summary: | summary |