The following data is part of a premarket notification filed by Tornier Sas with the FDA for Aequalis Ascend Flex Shoulder System.
| Device ID | K190521 |
| 510k Number | K190521 |
| Device Name: | Aequalis Ascend Flex Shoulder System |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | Tornier SAS 161 Rue Lavoisier Monbonnot Saint Martin, FR 38330 |
| Contact | Lamia Askri |
| Correspondent | Lamia Askri Tornier SAS 161 Rue Lavoisier Monbonnot Saint Martin, FR 38330 |
| Product Code | KWT |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-04 |
| Decision Date | 2019-06-12 |