Medical Device Manufacturer · US , Dallas , TX

Fx Shoulder USA, Inc. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2019

Recent clearances: Full Wedge Lateralized and Augmented Baseplates, FX V135(TM) Shoulder Prosthesis, Humeris® 135 Shoulder System

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fx Shoulder USA, Inc. Orthopedic ✕

11 devices

1-11 of 11

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