The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Aequalis Perform+ Shoulder System.
| Device ID | K150583 |
| 510k Number | K150583 |
| Device Name: | Aequalis PerFORM+ Shoulder System |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | TORNIER, INC. 10801 NESBITT AVENUE SOUTH Bloomington, MN 55437 |
| Contact | Kris Miller |
| Correspondent | Kris Miller TORNIER, INC. 10801 NESBITT AVENUE SOUTH Bloomington, MN 55437 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-09 |
| Decision Date | 2015-04-23 |
| Summary: | summary |