EasyClip® and EasyClip® Xpress— 510(k) K210582

Substantially Equivalent

Stryker GmbH

FDA 510(k) clearance K210582 for EasyClip® and EasyClip® Xpress, Substantially Equivalent on 2022-06-10. Applicant: Stryker GmbH.

Clearance details

Applicant: Stryker GmbH
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2021-02-26
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 JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.