The following data is part of a premarket notification filed by Tornier with the FDA for Aequalis Reversed Fracture Shoulder Prothesis.
| Device ID | K082120 |
| 510k Number | K082120 |
| Device Name: | AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | TORNIER 161 RUE LAVOISIER MONTBONNOT Saint-ismier Cedex, FR 38334 |
| Contact | Damien Guillaud |
| Correspondent | Damien Guillaud TORNIER 161 RUE LAVOISIER MONTBONNOT Saint-ismier Cedex, FR 38334 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-28 |
| Decision Date | 2008-10-24 |
| Summary: | summary |