The following data is part of a premarket notification filed by Tornier with the FDA for Aequalis Shoulder Prosthesis.
| Device ID | K980244 |
| 510k Number | K980244 |
| Device Name: | AEQUALIS SHOULDER PROSTHESIS |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | TORNIER 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf TORNIER 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-23 |
| Decision Date | 1999-08-23 |
| Summary: | summary |