PROFUSION BONE VOID FILLER KIT— 510(k) K031838

Substantially Equivalent

Biogeneration

FDA 510(k) clearance K031838 for PROFUSION BONE VOID FILLER KIT, Substantially Equivalent on 2003-10-30. Applicant: Biogeneration.

Clearance details

Applicant: Biogeneration
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2003-06-16
Decision date: 2003-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakeland, TN, 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.