GENEROS 80, GENEROS 60— 510(k) K051914

Substantially Equivalent

Berkeley Advanced Biomaterials, Inc.

FDA 510(k) clearance K051914 for GENEROS 80, GENEROS 60, Substantially Equivalent on 2005-11-03. Applicant: Berkeley Advanced Biomaterials, Inc..

Clearance details

Applicant: Berkeley Advanced Biomaterials, Inc.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2005-07-14
Decision date: 2005-11-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Berkeley, 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.