Full Wedge Lateralized and Augmented Baseplates— 510(k) K240278

Substantially Equivalent

Fx Shoulder USA, Inc.

FDA 510(k) clearance K240278 for Full Wedge Lateralized and Augmented Baseplates, Substantially Equivalent on 2024-05-15. Applicant: Fx Shoulder USA, Inc..

Clearance details

Applicant: Fx Shoulder USA, Inc.
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2024-02-01
Decision date: 2024-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Addison, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PHX

product code PHX

Death: 10
Injury: 9,705
Malfunction: 1,252
Total: 10,967

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.