GRAFTYS HBS— 510(k) K082498

Name: FDA 510(k) clearance K082498
Creator: U.S. Food and Drug Administration
Published: 2009-02-25

Substantially Equivalent

Graftys

FDA 510(k) clearance K082498 for GRAFTYS HBS, Substantially Equivalent on 2009-02-25. Applicant: Graftys. Device class: 2.

Clearance details

Applicant: Graftys
Product code: Code MQV
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2008-08-29
Decision date: 2009-02-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Aix En Provence, FR

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.