Home / Companies / Fx Shoulder USA, Inc.

Fx Shoulder USA, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K240278Full Wedge Lateralized and Augmented BaseplatesMay 15, 2024
K223801FX V135(TM) Shoulder ProsthesisJune 5, 2023
K222936Humeris® 135 Shoulder SystemNovember 7, 2022
K213117FX V135 Shoulder ProsthesisJune 7, 2022
K210790Lateralized and Augmented BaseplatesAugust 25, 2021
K201391Easytech® Anatomical Shoulder SystemFebruary 16, 2021
K191698TiN Coated Humeral HeadJuly 16, 2020
K191146Humelock TiN Coated GlenosphereJuly 15, 2020
K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityApril 29, 2020
K192799Glenoid Baseplate with ScrewFebruary 21, 2020
K19220632mm Glenosphere and Humeral CupOctober 8, 2019