Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System— 510(k) K220319

Substantially Equivalent

Stryker GmbH

FDA 510(k) clearance K220319 for Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System, Substantially Equivalent on 2022-06-10. Applicant: Stryker GmbH.

Clearance details

Applicant: Stryker GmbH
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2022-02-03
Decision date: 2022-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.