OSA RIGID INTERNAL FIXATION SYSTEM— 510(k) K021618

Substantially Equivalent

Osteomed Corp.

FDA 510(k) clearance K021618 for OSA RIGID INTERNAL FIXATION SYSTEM, Substantially Equivalent on 2002-08-08. Applicant: Osteomed Corp..

Clearance details

Applicant: Osteomed Corp.
Product code: Code JEY
Advisory panel: Dental
Date received: 2002-05-16
Decision date: 2002-08-08
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.