CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P— 510(k) K022622

Substantially Equivalent

Berkeley Advanced Biomaterials, Inc.

FDA 510(k) clearance K022622 for CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P, Substantially Equivalent on 2003-01-09. Applicant: Berkeley Advanced Biomaterials, Inc..

Clearance details

Applicant: Berkeley Advanced Biomaterials, Inc.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2002-08-07
Decision date: 2003-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Leandro, 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.