BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID— 510(k) K041616

Name: FDA 510(k) clearance K041616
Creator: U.S. Food and Drug Administration
Published: 2004-08-25

Substantially Equivalent

Orthos (Uk) Limited

FDA 510(k) clearance K041616 for BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID, Substantially Equivalent on 2004-08-25. Applicant: Orthos (Uk) Limited. Device class: 2.

Clearance details

Applicant: Orthos (Uk) Limited
Product code: Code MQV
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2004-06-15
Decision date: 2004-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bristol North Somerset, GB

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.