FDA 510(k) Applications Submitted by FX Shoulder USA, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K240278 |
02/01/2024 |
Full Wedge Lateralized and Augmented Baseplates |
FX Shoulder USA, Inc. |
| K222936 |
09/26/2022 |
Humeris« 135 Shoulder System |
FX Shoulder USA, Inc. |
| K210790 |
03/16/2021 |
Lateralized and Augmented Baseplates |
FX Shoulder USA, Inc. |
| K191146 |
04/30/2019 |
Humelock TiN Coated Glenosphere |
FX Shoulder USA, Inc. |
| K201391 |
05/27/2020 |
Easytech« Anatomical Shoulder System |
FX Shoulder USA, Inc. |
| K191698 |
06/25/2019 |
TiN Coated Humeral Head |
FX Shoulder USA, Inc. |
| K192206 |
08/14/2019 |
32mm Glenosphere and Humeral Cup |
FX Shoulder USA, Inc. |
| K213117 |
09/27/2021 |
FX V135 Shoulder Prosthesis |
FX Shoulder USA, Inc. |
| K192799 |
09/30/2019 |
Glenoid Baseplate with Screw |
FX Shoulder USA, Inc. |
| K193394 |
12/06/2019 |
Humeral Cup Stability & Humeral Cup 135/145o Stability |
FX Shoulder USA, Inc. |
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