BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM— 510(k) K053213

Substantially Equivalent

Berkeley Advanced Biomaterials, Inc.

FDA 510(k) clearance K053213 for BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM, Substantially Equivalent on 2006-07-06. Applicant: Berkeley Advanced Biomaterials, Inc..

Clearance details

Applicant: Berkeley Advanced Biomaterials, Inc.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2005-11-16
Decision date: 2006-07-06
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.