Univers Revers Modular Glenoid System, Half Augment Baseplate— 510(k) K200895

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K200895 for Univers Revers Modular Glenoid System, Half Augment Baseplate, Substantially Equivalent on 2020-08-13. Applicant: Arthrex, Inc..

Clearance details

Applicant: Arthrex, Inc.
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2020-04-03
Decision date: 2020-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, 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.