CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)— 510(k) K013072

Substantially Equivalent

Synthes

FDA 510(k) clearance K013072 for CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP), Substantially Equivalent on 2002-11-26. Applicant: Synthes.

Clearance details

Applicant: Synthes
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2001-09-13
Decision date: 2002-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, 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.