VariAx 2 Wrist Fusion System— 510(k) K151178

Substantially Equivalent

Stryker Trauma AG

FDA 510(k) clearance K151178 for VariAx 2 Wrist Fusion System, Substantially Equivalent on 2015-06-24. Applicant: Stryker Trauma AG.

Clearance details

Applicant: Stryker Trauma AG
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2015-05-04
Decision date: 2015-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schoenkirchen, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.