Fx Shoulder USA, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Fx Shoulder USA, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Full Wedge Lateralized and Augmented Baseplates, FX V135(TM) Shoulder Prosthesis, Humeris® 135 Shoulder System
11
Total
11
Cleared
0
Denied
Fx Shoulder USA, Inc. has 11 FDA 510(k) cleared orthopedic devices. Based in Dallas, US.
Latest FDA clearance: May 2024. Active since 2019.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Fx Shoulder USA, Inc.
11 devices
Cleared
May 15, 2024
Full Wedge Lateralized and Augmented Baseplates
Orthopedic
104d
Cleared
Jun 05, 2023
FX V135(TM) Shoulder Prosthesis
Orthopedic
168d
Cleared
Nov 07, 2022
Humeris® 135 Shoulder System
Orthopedic
42d
Cleared
Jun 07, 2022
FX V135 Shoulder Prosthesis
Orthopedic
253d
Cleared
Aug 25, 2021
Lateralized and Augmented Baseplates
Orthopedic
162d
Cleared
Feb 16, 2021
Easytech® Anatomical Shoulder System
Orthopedic
265d
Cleared
Jul 16, 2020
TiN Coated Humeral Head
Orthopedic
387d
Cleared
Jul 15, 2020
Humelock TiN Coated Glenosphere
Orthopedic
442d
Cleared
Apr 29, 2020
Humeral Cup Stability & Humeral Cup 135/145o Stability
Orthopedic
145d
Cleared
Feb 21, 2020
Glenoid Baseplate with Screw
Orthopedic
144d
Cleared
Oct 08, 2019
32mm Glenosphere and Humeral Cup
Orthopedic
55d