Stryker MEDPOR TITAN 3D Orbital Floor Implant— 510(k) K142568

Substantially Equivalent

Stryker

FDA 510(k) clearance K142568 for Stryker MEDPOR TITAN 3D Orbital Floor Implant, Substantially Equivalent on 2015-05-05. Applicant: Stryker.

Clearance details

Applicant: Stryker
Product code: Code JEY
Advisory panel: Dental
Date received: 2014-09-12
Decision date: 2015-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
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.