GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES— 510(k) K050666

Substantially Equivalent

Berkeley Advanced Biomaterials, Inc.

FDA 510(k) clearance K050666 for GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES, Substantially Equivalent on 2005-04-11. Applicant: Berkeley Advanced Biomaterials, Inc..

Clearance details

Applicant: Berkeley Advanced Biomaterials, Inc.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2005-03-14
Decision date: 2005-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkeley, CA, US

Download summary PDF View on FDA.gov ↗

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.