The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Comprehensive Segmental Revision System (srs).
| Device ID | K173411 |
| 510k Number | K173411 |
| Device Name: | Comprehensive Segmental Revision System (SRS) |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | Biomet Manufacturing Corp. 56 East Bell Drive Warsaw, IN 46580 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres Biomet Manufacturing Corp. 56 East Bell Drive Warsaw, IN 46580 |
| Product Code | PHX |
| Subsequent Product Code | JDC |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| Subsequent Product Code | MBF |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-01 |
| Decision Date | 2018-02-08 |
| Summary: | summary |