The following data is part of a premarket notification filed by Tornier with the FDA for Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prosthesis.
| Device ID | K112144 |
| 510k Number | K112144 |
| Device Name: | AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | TORNIER 161 RUE LAVOISIER Montbonnot, Saint-ismier, FR 38334 |
| Contact | Severine Bonneton |
| Correspondent | Severine Bonneton 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 | 2011-07-26 |
| Decision Date | 2012-03-13 |
| Summary: | summary |