ALLOGRAN-N-BONE VOID FILLER— 510(k) K043514

Substantially Equivalent

Biocomposites, Ltd.

FDA 510(k) clearance K043514 for ALLOGRAN-N-BONE VOID FILLER, Substantially Equivalent on 2005-01-21. Applicant: Biocomposites, Ltd..

Clearance details

Applicant: Biocomposites, Ltd.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2004-12-20
Decision date: 2005-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keele, GB

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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.