TORNIER TOTAL ELBOW PROSTHESIS— 510(k) K000003

Substantially Equivalent

Tornier

FDA 510(k) clearance K000003 for TORNIER TOTAL ELBOW PROSTHESIS, Substantially Equivalent on 2000-10-02. Applicant: Tornier.

Clearance details

Applicant: Tornier
Product code: Code JDC
Advisory panel: Orthopedic
Date received: 2000-01-03
Decision date: 2000-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasant Hill, CA, US

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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.