The following data is part of a premarket notification filed by Tornier with the FDA for Modification To Aequalis Shoulder Fracture System.
| Device ID | K003728 |
| 510k Number | K003728 |
| Device Name: | MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | TORNIER 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf TORNIER 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-04 |
| Decision Date | 2000-12-20 |