NORMED MANDIBULAR FIXATION SYSTEM— 510(k) K010118

Substantially Equivalent

Osteomedics, Inc.

FDA 510(k) clearance K010118 for NORMED MANDIBULAR FIXATION SYSTEM, Substantially Equivalent on 2001-08-14. Applicant: Osteomedics, Inc..

Clearance details

Applicant: Osteomedics, Inc.
Product code: Code JEY
Advisory panel: Dental
Date received: 2001-01-16
Decision date: 2001-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paramus, NJ, US

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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.