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FDA 510(k)

MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)

K-Number: K123691 · 2013-01-31

ApplicantMedtronic Sofamor Danek, Inc.
Decision Date2013-01-31
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek, Inc.. It received FDA 510(k) clearance on 2013-01-31 under 510(k) number K123691. 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 MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)?

MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM) is a medical device that received FDA 510(k) clearance on 2013-01-31. The listed applicant is Medtronic Sofamor Danek, Inc.. The 510(k) number is K123691.

When did MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM) receive FDA 510(k) clearance?

MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM) received FDA 510(k) clearance on 2013-01-31, under 510(k) number K123691.

Who is the listed applicant for MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)?

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

What is the FDA product code for MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)?

The FDA product code for MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM) is MQV.

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Related Devices (Code: MQV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

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

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