CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ— 510(k) K030266

Name: FDA 510(k) clearance K030266
Creator: U.S. Food and Drug Administration
Published: 2003-02-20

Substantially Equivalent

Berkeley Advanced Biomaterials, Inc.

FDA 510(k) clearance K030266 for CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ, Substantially Equivalent on 2003-02-20. Applicant: Berkeley Advanced Biomaterials, Inc.. Device class: 2.

Clearance details

Applicant: Berkeley Advanced Biomaterials, Inc.
Product code: Code MQV
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2003-01-27
Decision date: 2003-02-20
Decision: Substantially Equivalent
Clearance type: Special
Location: San Leandro, CA, US

Download summary PDF View on FDA.gov ↗

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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.