Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Fx Shoulder USA, Inc.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories3
Latest Approval2024-05-15
TypeNumberDevice NameCodeDate
510(k) K240278 Full Wedge Lateralized and Augmented Baseplates PHX 2024-05-15 View
510(k) K223801 FX V135(TM) Shoulder Prosthesis PHX 2023-06-05 View
510(k) K222936 Humeris® 135 Shoulder System PHX 2022-11-07 View
510(k) K213117 FX V135 Shoulder Prosthesis PHX 2022-06-07 View
510(k) K210790 Lateralized and Augmented Baseplates PHX 2021-08-25 View
510(k) K201391 Easytech® Anatomical Shoulder System PKC 2021-02-16 View
510(k) K191698 TiN Coated Humeral Head KWT 2020-07-16 View
510(k) K191146 Humelock TiN Coated Glenosphere PHX 2020-07-15 View
510(k) K193394 Humeral Cup Stability & Humeral Cup 135/145o Stability PHX 2020-04-29 View
510(k) K192799 Glenoid Baseplate with Screw PHX 2020-02-21 View
510(k) K192206 32mm Glenosphere and Humeral Cup PHX 2019-10-08 View
↑