The following data is part of a premarket notification filed by Tornier with the FDA for Aequalis Reversed Shoulder Prosthesis.
| Device ID | K081059 |
| 510k Number | K081059 |
| Device Name: | AEQUALIS REVERSED SHOULDER PROSTHESIS |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | TORNIER 161 RUE LAVOISIER Montbonnot, Saint-ismier, FR 38334 |
| Contact | Damien Guillaud |
| Correspondent | Damien Guillaud 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 | 2008-04-14 |
| Decision Date | 2008-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700386935930 | K081059 | 000 |
| 03700386935831 | K081059 | 000 |
| 03700386935848 | K081059 | 000 |
| 03700386935855 | K081059 | 000 |
| 03700386935862 | K081059 | 000 |
| 03700386935879 | K081059 | 000 |
| 03700386935886 | K081059 | 000 |
| 03700386935893 | K081059 | 000 |
| 03700386935909 | K081059 | 000 |
| 03700386935916 | K081059 | 000 |
| 03700386935923 | K081059 | 000 |
| 03700386935824 | K081059 | 000 |