CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12— 510(k) K090871

Substantially Equivalent

Bonesupport AB

FDA 510(k) clearance K090871 for CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12, Substantially Equivalent on 2009-09-04. Applicant: Bonesupport AB.

Clearance details

Applicant: Bonesupport AB
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2009-03-30
Decision date: 2009-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lund, SE

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.