The following data is part of a premarket notification filed by Tornier with the FDA for Aequalis Reversed Shoulder Prosthesis.
Device ID | K100142 |
510k Number | K100142 |
Device Name: | AEQUALIS REVERSED SHOULDER PROSTHESIS |
Classification | Shoulder Prosthesis, Reverse Configuration |
Applicant | TORNIER 161 RUE LAVOISIER Montbonnot, Saint-ismier, FR 38334 |
Contact | Severien Bonneton |
Correspondent | Severien Bonneton TORNIER 161 RUE LAVOISIER Montbonnot, Saint-ismier, FR 38334 |
Product Code | PHX |
Subsequent Product Code | HSD |
Subsequent Product Code | KWS |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-01-19 |
Decision Date | 2010-05-06 |
Summary: | summary |