Arthrex Univers Revers CA Heads and Adapters— 510(k) K151527

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K151527 for Arthrex Univers Revers CA Heads and Adapters, Substantially Equivalent on 2016-04-19. Applicant: Arthrex, Inc..

Clearance details

Applicant: Arthrex, Inc.
Product code: Code HSD
Advisory panel: Orthopedic
Date received: 2015-06-08
Decision date: 2016-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
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.