The following data is part of a premarket notification filed by Tornier with the FDA for Aequalis Press-fit Shoulder Prosthesis.
| Device ID | K011942 |
| 510k Number | K011942 |
| Device Name: | AEQUALIS PRESS-FIT SHOULDER PROSTHESIS |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | TORNIER RUE DOYEN GOSSE St. Ismier, FR 38330 |
| Contact | Irene Gosset |
| Correspondent | Irene Gosset TORNIER RUE DOYEN GOSSE St. Ismier, FR 38330 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-21 |
| Decision Date | 2001-07-13 |
| Summary: | summary |