The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Aequalis Shoulder Fracture And Shoulder Systems.
| Device ID | K081707 |
| 510k Number | K081707 |
| Device Name: | AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | TORNIER, INC. 100 CAPITAL DRIVE SUITE 201 Warsaw, IN 46582 |
| Contact | Jeff Ondrla |
| Correspondent | Jeff Ondrla TORNIER, INC. 100 CAPITAL DRIVE SUITE 201 Warsaw, IN 46582 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-17 |
| Decision Date | 2008-07-17 |
| Summary: | summary |