COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES— 510(k) K053189

Substantially Equivalent

Zimmer, Inc.

FDA 510(k) clearance K053189 for COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES, Substantially Equivalent on 2005-12-09. Applicant: Zimmer, Inc..

Clearance details

Applicant: Zimmer, Inc.
Product code: Code JDC
Advisory panel: Orthopedic
Date received: 2005-11-15
Decision date: 2005-12-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, 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.