The following data is part of a premarket notification filed by Tornier with the FDA for Aequalis Reversed Shoulder Prosthesis.
| Device ID | K050316 |
| 510k Number | K050316 |
| Device Name: | AEQUALIS REVERSED SHOULDER PROSTHESIS |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | TORNIER 161 RUE LAVOISIER Montbonnot, Saint-ismier, FR 38334 |
| Contact | Mireille Lemery |
| Correspondent | Mireille Lemery TORNIER 161 RUE LAVOISIER Montbonnot, Saint-ismier, FR 38334 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-09 |
| Decision Date | 2005-03-16 |
| Summary: | summary |