The following data is part of a premarket notification filed by Tornier Sas with the FDA for Aequalis Reversed Shoulder Prosthesis.
| Device ID | K140478 |
| 510k Number | K140478 |
| Device Name: | AEQUALIS REVERSED SHOULDER PROSTHESIS |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | Tornier SAS 161 RUE LAVOISIER Montbonnot Saint Martin, FR 38330 |
| Contact | Magalie Hennequin |
| Correspondent | Magalie Hennequin Tornier SAS 161 RUE LAVOISIER Montbonnot Saint Martin, FR 38330 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-26 |
| Decision Date | 2014-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700386952890 | K140478 | 000 |
| 03700386952791 | K140478 | 000 |
| 03700386952807 | K140478 | 000 |
| 03700386952814 | K140478 | 000 |
| 03700386952821 | K140478 | 000 |
| 03700386952838 | K140478 | 000 |
| 03700386952845 | K140478 | 000 |
| 03700386952852 | K140478 | 000 |
| 03700386952869 | K140478 | 000 |
| 03700386952876 | K140478 | 000 |
| 03700386952883 | K140478 | 000 |
| 03700386952784 | K140478 | 000 |