The following data is part of a premarket notification filed by Tornier with the FDA for Modification To Aequalis Shoulder Fracture System; Aequalis Shoulder System.
| Device ID | K043077 |
| 510k Number | K043077 |
| Device Name: | MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | TORNIER 161 RUE LAVOISIER Montbonnot, Saint-ismier, FR 38334 |
| Contact | Lemery Mireille |
| Correspondent | Lemery Mireille TORNIER 161 RUE LAVOISIER Montbonnot, Saint-ismier, 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 | 2004-11-08 |
| Decision Date | 2004-12-17 |
| Summary: | summary |