The following data is part of a premarket notification filed by Tornier with the FDA for Modification To Aequalis Shoulder System.
| Device ID | K012212 |
| 510k Number | K012212 |
| Device Name: | MODIFICATION TO AEQUALIS SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | TORNIER ZIRST-161, RUE LAVOISIER Montbonnot, FR 38330 |
| Contact | Irene Gosset |
| Correspondent | Irene Gosset TORNIER ZIRST-161, RUE LAVOISIER Montbonnot, FR 38330 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-16 |
| Decision Date | 2001-08-15 |
| Summary: | summary |