Stryker Resorbable Fixation System— 510(k) K213777

Substantially Equivalent

Stryker Leibinger Micro Implants

FDA 510(k) clearance K213777 for Stryker Resorbable Fixation System, Substantially Equivalent on 2022-02-04. Applicant: Stryker Leibinger Micro Implants.

Clearance details

Applicant: Stryker Leibinger Micro Implants
Product code: Code JEY
Advisory panel: Dental
Date received: 2021-12-03
Decision date: 2022-02-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Portage, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JEY

product code JEY

Injury: 1,542
Malfunction: 2,292
Total: 3,834

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.