510(k) K980502— OSTEONICS TOTAL ELBOW SYSTEM

Substantially Equivalent

Osteonics Corp.

Clearance details

Applicant: Osteonics Corp.
Product code: Code JDC
Advisory panel: Orthopedic
Date received: 1998-02-09
Decision date: 1998-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

Adverse events under product code JDC

product code JDC

Injury: 1,050
Total: 1,050

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.