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FDA 510(k)

CLEARED UNDER GRAFTON II EDBM

K-Number: K122513 · 2013-03-06

ApplicantMedtronic Sofamor Danek, Inc.
Decision Date2013-03-06
Product CodeMBP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CLEARED UNDER 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 2013-03-06 under 510(k) number K122513. The device is classified under product code MBP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARED UNDER GRAFTON II EDBM?

CLEARED UNDER GRAFTON II EDBM is a medical device that received FDA 510(k) clearance on 2013-03-06. The listed applicant is Medtronic Sofamor Danek, Inc.. The 510(k) number is K122513.

When did CLEARED UNDER GRAFTON II EDBM receive FDA 510(k) clearance?

CLEARED UNDER GRAFTON II EDBM received FDA 510(k) clearance on 2013-03-06, under 510(k) number K122513.

Who is the listed applicant for CLEARED UNDER 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 CLEARED UNDER GRAFTON II EDBM?

The FDA product code for CLEARED UNDER GRAFTON II EDBM is MBP.

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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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