FDA · official record K082917Substantially Equivalent

MASTERGRAFT RESORBABLE CERAMIC GRANULES

Name: MASTERGRAFT RESORBABLE CERAMIC GRANULES — FDA K082917
Creator: Medtronic Sofamor Danek
Keywords: MASTERGRAFT RESORBABLE CERAMIC GRANULES, MASTERGRAFT RESORBABLE CERAMIC GRANULES, K082917, LYC, FDA

United StatesLYCMedtronic Sofamor Danek

Verified

Official record identity

FDA application number: K082917
Decision date: January 09, 2009
Published decision: Substantially Equivalent

Classification

Product code: LYC

Published parties

Applicant: Medtronic Sofamor Danek

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2008-09-30
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3930

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.