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FDA 510(k)

MASTERGRAFT RESORBABLE CERAMIC GRANULES

K-Number: K082918 · 2009-02-09

ApplicantMedtronic Sofamor Danek
Decision Date2009-02-09
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MASTERGRAFT RESORBABLE CERAMIC GRANULES is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2009-02-09 under 510(k) number K082918. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MASTERGRAFT RESORBABLE CERAMIC GRANULES?

MASTERGRAFT RESORBABLE CERAMIC GRANULES is a medical device that received FDA 510(k) clearance on 2009-02-09. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K082918.

When did MASTERGRAFT RESORBABLE CERAMIC GRANULES receive FDA 510(k) clearance?

MASTERGRAFT RESORBABLE CERAMIC GRANULES received FDA 510(k) clearance on 2009-02-09, under 510(k) number K082918.

Who is the listed applicant for MASTERGRAFT RESORBABLE CERAMIC GRANULES?

The FDA 510(k) record lists Medtronic Sofamor Danek as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MASTERGRAFT RESORBABLE CERAMIC GRANULES?

The FDA product code for MASTERGRAFT RESORBABLE CERAMIC GRANULES is MQV.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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