Fx Shoulder USA, Inc.

Medical device manufacturer in Addison, TX.

11510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K240278Full Wedge Lateralized and Augmented BaseplatesPHX · Traditional 05/15/2024SE
K223801FX V135(TM) Shoulder ProsthesisPHX · Traditional 06/05/2023SE
K222936Humeris® 135 Shoulder SystemPHX · Traditional 11/07/2022SE
K213117FX V135 Shoulder ProsthesisPHX · Traditional 06/07/2022SE
K210790Lateralized and Augmented BaseplatesPHX · Traditional 08/25/2021SE
K201391Easytech® Anatomical Shoulder SystemPKC · Traditional 02/16/2021SE
K191698TiN Coated Humeral HeadKWT · Traditional 07/16/2020SE
K191146Humelock TiN Coated GlenospherePHX · Traditional 07/15/2020SE
K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityPHX · Traditional 04/29/2020SE
K192799Glenoid Baseplate with ScrewPHX · Traditional 02/21/2020SE
K19220632mm Glenosphere and Humeral CupPHX · Traditional 10/08/2019SE