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 |