The following data is part of a premarket notification filed by Tornier Sas with the FDA for Aequalis Fx2.
Device ID | K152966 |
510k Number | K152966 |
Device Name: | Aequalis Fx2 |
Classification | Shoulder Prosthesis, Reverse Configuration |
Applicant | Tornier SAS 161 RUE LAVOISIER Montbonnot Saint Martin, FR 38330 |
Contact | Jovila Dodi |
Correspondent | Jovila Dodi Tornier SAS 161 RUE LAVOISIER Montbonnot Saint Martin, FR 38330 |
Product Code | PHX |
Subsequent Product Code | HSD |
Subsequent Product Code | KWS |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-10-07 |
Decision Date | 2016-01-14 |
Summary: | summary |