The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Aequalis Ascend Modular Reverse Shoulder System.
| Device ID | K112615 |
| 510k Number | K112615 |
| Device Name: | AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | TORNIER, INC. 7701 FRANCE AVE SOUTH SUITE 600 Edina, MN 55435 |
| Contact | Brahim Hadri |
| Correspondent | Brahim Hadri TORNIER, INC. 7701 FRANCE AVE SOUTH SUITE 600 Edina, MN 55435 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-08 |
| Decision Date | 2011-10-11 |
| Summary: | summary |