The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Reunion Rsa Shoulder System.
| Device ID | K130895 |
| 510k Number | K130895 |
| Device Name: | REUNION RSA SHOULDER SYSTEM |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Estela Celi |
| Correspondent | Estela Celi HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-01 |
| Decision Date | 2013-12-27 |
| Summary: | summary |