PEEK CUSTOMIZED CRAIAL IMPLANT KIT— 510(k) K121153

Substantially Equivalent

Stryker

FDA 510(k) clearance K121153 for PEEK CUSTOMIZED CRAIAL IMPLANT KIT, Substantially Equivalent on 2012-09-14. Applicant: Stryker.

Clearance details

Applicant: Stryker
Product code: Code GWO
Advisory panel: Neurology
Date received: 2012-04-16
Decision date: 2012-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portage, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWO

product code GWO

Malfunction: 583
Total: 583

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.