The following data is part of a premarket notification filed by Tornier, Sas with the FDA for Aequalis Reversed Shoulder Prosthesis.
| Device ID | K132285 |
| 510k Number | K132285 |
| Device Name: | AEQUALIS REVERSED SHOULDER PROSTHESIS |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | TORNIER, SAS 161. RUE LAVOISIER Montbonnot Saint Martin, FR 38330 |
| Contact | Magalie Hennequin |
| Correspondent | Magalie Hennequin TORNIER, SAS 161. RUE LAVOISIER Montbonnot Saint Martin, FR 38330 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-23 |
| Decision Date | 2013-12-05 |
| Summary: | summary |