Stryker Upper-Face AXS screws and Mid-Face AXS screws— 510(k) K172572

Substantially Equivalent

Stryker

FDA 510(k) clearance K172572 for Stryker Upper-Face AXS screws and Mid-Face AXS screws, Substantially Equivalent on 2017-10-31. Applicant: Stryker.

Clearance details

Applicant: Stryker
Product code: Code JEY
Advisory panel: Dental
Date received: 2017-08-28
Decision date: 2017-10-31
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.