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FDA 510(k)

MODIFICATION TO EQUATION FIXATION SYSTEM

K-Number: K042453 · 2004-10-07

ApplicantMedtronic Sofamor Danek, Inc.
Decision Date2004-10-07
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO EQUATION FIXATION SYSTEM 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 2004-10-07 under 510(k) number K042453. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO EQUATION FIXATION SYSTEM?

MODIFICATION TO EQUATION FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-10-07. The listed applicant is Medtronic Sofamor Danek, Inc.. The 510(k) number is K042453.

When did MODIFICATION TO EQUATION FIXATION SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO EQUATION FIXATION SYSTEM received FDA 510(k) clearance on 2004-10-07, under 510(k) number K042453.

Who is the listed applicant for MODIFICATION TO EQUATION FIXATION SYSTEM?

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 MODIFICATION TO EQUATION FIXATION SYSTEM?

The FDA product code for MODIFICATION TO EQUATION FIXATION SYSTEM is MNI.

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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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