OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM— 510(k) K140978

Substantially Equivalent

Osteomed

FDA 510(k) clearance K140978 for OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM, Substantially Equivalent on 2014-12-18. Applicant: Osteomed.

Clearance details

Applicant: Osteomed
Product code: Code JEY
Advisory panel: Dental
Date received: 2014-04-16
Decision date: 2014-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Addison, TX, 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.