The following data is part of a premarket notification filed by Tornier Sas with the FDA for Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis.
Device ID | K151293 |
510k Number | K151293 |
Device Name: | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis |
Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
Applicant | Tornier SAS 161 Rue Lavoisier Monbonnot Saint Martin, FR 38334 |
Contact | Severine Bonneton |
Correspondent | Severine Bonneton Tornier SAS 161 Rue Lavoisier Monbonnot Saint Martin, FR 38334 |
Product Code | KWS |
Subsequent Product Code | HSD |
Subsequent Product Code | KWT |
Subsequent Product Code | PHX |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-05-15 |
Decision Date | 2015-09-24 |
Summary: | summary |