The following data is part of a premarket notification filed by Tornier Sas with the FDA for Aequalis Fx2.
| Device ID | K141345 |
| 510k Number | K141345 |
| Device Name: | AEQUALIS FX2 |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | Tornier SAS 161 RUE LAVOISIER Montbonnot Saint Martin, FR 38330 |
| Contact | Maud Andriollo |
| Correspondent | Maud Andriollo Tornier SAS 161 RUE LAVOISIER Montbonnot Saint Martin, FR 38330 |
| Product Code | PHX |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-22 |
| Decision Date | 2014-11-18 |
| Summary: | summary |