FDA 510(k) Applications Submitted by FX Shoulder USA, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
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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