The following data is part of a premarket notification filed by Tornier with the FDA for Aequalis Shoulder System.
Device ID | K041339 |
510k Number | K041339 |
Device Name: | AEQUALIS SHOULDER SYSTEM |
Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
Applicant | TORNIER ZIRST-161, RUE LAVOISIER Montbonnot, FR 38330 |
Contact | Mireille Lemery |
Correspondent | Mireille Lemery TORNIER ZIRST-161, RUE LAVOISIER Montbonnot, FR 38330 |
Product Code | KWS |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-05-20 |
Decision Date | 2004-06-17 |
Summary: | summary |