The following data is part of a premarket notification filed by Tornier Sas with the FDA for Aequalis(tm) Ascent(tm) Flex Shoulder System.
| Device ID | K140082 |
| 510k Number | K140082 |
| Device Name: | AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | Tornier SAS 161 RUE LAVOISIER Montbonnot Saint Martin, FR 38330 |
| Contact | Aymen Azaiez |
| Correspondent | Aymen Azaiez Tornier SAS 161 RUE LAVOISIER Montbonnot Saint Martin, FR 38330 |
| Product Code | PHX |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-13 |
| Decision Date | 2014-07-18 |
| Summary: | summary |