BONESOURCE BVF— 510(k) K031435

Name: FDA 510(k) clearance K031435
Creator: U.S. Food and Drug Administration
Published: 2003-08-04

Substantially Equivalent

Howmedica Osteonics

FDA 510(k) clearance K031435 for BONESOURCE BVF, Substantially Equivalent on 2003-08-04. Applicant: Howmedica Osteonics. Device class: 2.

Clearance details

Applicant: Howmedica Osteonics
Product code: Code MQV
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2003-05-06
Decision date: 2003-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

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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.