OSSATURA BCP BONE VOID FILLER— 510(k) K030131

Substantially Equivalent

Isotis NV

FDA 510(k) clearance K030131 for OSSATURA BCP BONE VOID FILLER, Substantially Equivalent on 2003-05-20. Applicant: Isotis NV.

Clearance details

Applicant: Isotis NV
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2003-01-14
Decision date: 2003-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, 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.