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FDA 510(k)

MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX

K-Number: K130335 · 2013-04-19

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2013-04-19
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2013-04-19 under 510(k) number K130335. 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 STRIP; MASTERGRAFT ULTRAMATRIX?

MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX is a medical device that received FDA 510(k) clearance on 2013-04-19. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K130335.

When did MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX receive FDA 510(k) clearance?

MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX received FDA 510(k) clearance on 2013-04-19, under 510(k) number K130335.

Who is the listed applicant for MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX?

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

What is the FDA product code for MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX?

The FDA product code for MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX 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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