Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 FDA decision2024-05-15
TypeNumberDevice NameCodeDateActions
510(k) K240278 Full Wedge Lateralized and Augmented BaseplatesPHX2024-05-15 View
510(k) K223801 FX V135(TM) Shoulder ProsthesisPHX2023-06-05 View
510(k) K222936 Humeris® 135 Shoulder SystemPHX2022-11-07 View
510(k) K213117 FX V135 Shoulder ProsthesisPHX2022-06-07 View
510(k) K210790 Lateralized and Augmented BaseplatesPHX2021-08-25 View
510(k) K201391 Easytech® Anatomical Shoulder SystemPKC2021-02-16 View
510(k) K191698 TiN Coated Humeral HeadKWT2020-07-16 View
510(k) K191146 Humelock TiN Coated GlenospherePHX2020-07-15 View
510(k) K193394 Humeral Cup Stability & Humeral Cup 135/145o StabilityPHX2020-04-29 View
510(k) K192799 Glenoid Baseplate with ScrewPHX2020-02-21 View
510(k) K192206 32mm Glenosphere and Humeral CupPHX2019-10-08 View
↑