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FDA 510(k)

KOBRA GPS FIXATION SYSTEM

K-Number: K042859 · 2004-11-24

ApplicantMedtronic Vertelink, Inc.
Decision Date2004-11-24
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KOBRA GPS FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vertelink, Inc.. It received FDA 510(k) clearance on 2004-11-24 under 510(k) number K042859. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOBRA GPS FIXATION SYSTEM?

KOBRA GPS FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-11-24. The listed applicant is Medtronic Vertelink, Inc.. The 510(k) number is K042859.

When did KOBRA GPS FIXATION SYSTEM receive FDA 510(k) clearance?

KOBRA GPS FIXATION SYSTEM received FDA 510(k) clearance on 2004-11-24, under 510(k) number K042859.

Who is the listed applicant for KOBRA GPS FIXATION SYSTEM?

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

What is the FDA product code for KOBRA GPS FIXATION SYSTEM?

The FDA product code for KOBRA GPS FIXATION SYSTEM is KWQ.

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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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