MASTERGRAFT RESORBABLE CERAMIC GRANULES— 510(k) K082917

Name: FDA 510(k) clearance K082917
Creator: U.S. Food and Drug Administration
Published: 2009-01-09

Substantially Equivalent

Medtronic Sofamor Danek

FDA 510(k) clearance K082917 for MASTERGRAFT RESORBABLE CERAMIC GRANULES, Substantially Equivalent on 2009-01-09. Applicant: Medtronic Sofamor Danek. Device class: 2.

Clearance details

Applicant: Medtronic Sofamor Danek
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2008-09-30
Decision date: 2009-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.