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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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