EOVIA CALCIUM PHOSPHATE CERAMIC— 510(k) K040514

Substantially Equivalent

Ortho Tec, LLC

FDA 510(k) clearance K040514 for EOVIA CALCIUM PHOSPHATE CERAMIC, Substantially Equivalent on 2004-05-03. Applicant: Ortho Tec, LLC.

Clearance details

Applicant: Ortho Tec, LLC
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2004-02-27
Decision date: 2004-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: California, CA, US

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Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

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.