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FDA 510(k)

Ziehm RFD 3D Tracker

K-Number: K180816 · 2018-07-11

ApplicantMedtronic Navigation
Decision Date2018-07-11
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Ziehm RFD 3D Tracker is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation. It received FDA 510(k) clearance on 2018-07-11 under 510(k) number K180816. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ziehm RFD 3D Tracker?

Ziehm RFD 3D Tracker is a medical device that received FDA 510(k) clearance on 2018-07-11. The listed applicant is Medtronic Navigation. The 510(k) number is K180816.

When did Ziehm RFD 3D Tracker receive FDA 510(k) clearance?

Ziehm RFD 3D Tracker received FDA 510(k) clearance on 2018-07-11, under 510(k) number K180816.

Who is the listed applicant for Ziehm RFD 3D Tracker?

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

What is the FDA product code for Ziehm RFD 3D Tracker?

The FDA product code for Ziehm RFD 3D Tracker is OLO.

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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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