The following data is part of a premarket notification filed by Tornier Sas with the FDA for Aequalis Ascend Flex Shoulder System.
| Device ID | K122698 |
| 510k Number | K122698 |
| Device Name: | AEQUALIS ASCEND FLEX SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | Tornier SAS 10801 Nesbitt Avenue South Bloomington, MN 55437 |
| Contact | Brahim Hadri |
| Correspondent | Brahim Hadri Tornier SAS 10801 Nesbitt Avenue South Bloomington, MN 55437 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-04 |
| Decision Date | 2013-01-08 |
| Summary: | summary |