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FDA 510(k)

TRAVERSE OCT SPINAL FIXATION SYSTEM

K-Number: K062879 · 2006-12-22

ApplicantMedtronic Sofamor Danek, Inc.
Decision Date2006-12-22
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRAVERSE OCT SPINAL 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 2006-12-22 under 510(k) number K062879. 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 TRAVERSE OCT SPINAL FIXATION SYSTEM?

TRAVERSE OCT SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2006-12-22. The listed applicant is Medtronic Sofamor Danek, Inc.. The 510(k) number is K062879.

When did TRAVERSE OCT SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

TRAVERSE OCT SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2006-12-22, under 510(k) number K062879.

Who is the listed applicant for TRAVERSE OCT SPINAL 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 TRAVERSE OCT SPINAL FIXATION SYSTEM?

The FDA product code for TRAVERSE OCT SPINAL FIXATION SYSTEM is MNI.

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Related Devices (Code: 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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