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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700386940484 | K140082 | 000 |
| 03700386940354 | K140082 | 000 |
| 03700386940347 | K140082 | 000 |
| 03700386940330 | K140082 | 000 |
| 03700386940323 | K140082 | 000 |
| 03700386940316 | K140082 | 000 |
| 03700386940309 | K140082 | 000 |
| 03700386940293 | K140082 | 000 |
| 03700386940286 | K140082 | 000 |
| 03700386940279 | K140082 | 000 |
| 03700386940262 | K140082 | 000 |
| 03700386940361 | K140082 | 000 |
| 03700386940378 | K140082 | 000 |
| 03700386940477 | K140082 | 000 |
| 03700386940460 | K140082 | 000 |
| 03700386940453 | K140082 | 000 |
| 03700386940446 | K140082 | 000 |
| 03700386940439 | K140082 | 000 |
| 03700386940422 | K140082 | 000 |
| 03700386940415 | K140082 | 000 |
| 03700386940408 | K140082 | 000 |
| 03700386940392 | K140082 | 000 |
| 03700386940385 | K140082 | 000 |
| 03700386940255 | K140082 | 000 |