The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Comprehensive Reverse Shoulder - Titanium Glenosphere.
| Device ID | K131353 |
| 510k Number | K131353 |
| Device Name: | COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE Warsaw, IN 46582 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE Warsaw, IN 46582 |
| Product Code | PHX |
| Subsequent Product Code | KWS |
| Subsequent Product Code | PAO |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-10 |
| Decision Date | 2013-10-08 |
| Summary: | summary |