Univers Revers Humeral Cup Implant— 510(k) K221232

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K221232 for Univers Revers Humeral Cup Implant, Substantially Equivalent on 2022-05-19. Applicant: Arthrex, Inc..

Clearance details

Applicant: Arthrex, Inc.
Product code: Code HSD
Advisory panel: Orthopedic
Date received: 2022-04-29
Decision date: 2022-05-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSD

product code HSD

Injury: 3,425
Malfunction: 531
Total: 3,956

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.