The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Aequalis Perform Reversed Glenoid, Aequalis Perform + Reversed Glenoid.
| Device ID | K183696 |
| 510k Number | K183696 |
| Device Name: | Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | Tornier, Inc. 10801 Nesbitt Avenue South Bloomington, MN 55347 |
| Contact | Moyees Kamara |
| Correspondent | Moyees Kamara Tornier, Inc. 10801 Nesbitt Avenue South Bloomington, MN 55347 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-31 |
| Decision Date | 2019-01-30 |
| Summary: | summary |