The following data is part of a premarket notification filed by Tornier Sas with the FDA for Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis.
| Device ID | K151293 |
| 510k Number | K151293 |
| Device Name: | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | Tornier SAS 161 Rue Lavoisier Monbonnot Saint Martin, FR 38334 |
| Contact | Severine Bonneton |
| Correspondent | Severine Bonneton Tornier SAS 161 Rue Lavoisier Monbonnot Saint Martin, FR 38334 |
| Product Code | KWS |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWT |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-15 |
| Decision Date | 2015-09-24 |
| Summary: | summary |