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FDA 510(k)

NavLock Trackers, Robotic Reference Frame

K-Number: K182104 · 2018-11-02

ApplicantMedtronic Navigation
Decision Date2018-11-02
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NavLock Trackers, Robotic Reference Frame is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation. It received FDA 510(k) clearance on 2018-11-02 under 510(k) number K182104. 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 NavLock Trackers, Robotic Reference Frame?

NavLock Trackers, Robotic Reference Frame is a medical device that received FDA 510(k) clearance on 2018-11-02. The listed applicant is Medtronic Navigation. The 510(k) number is K182104.

When did NavLock Trackers, Robotic Reference Frame receive FDA 510(k) clearance?

NavLock Trackers, Robotic Reference Frame received FDA 510(k) clearance on 2018-11-02, under 510(k) number K182104.

Who is the listed applicant for NavLock Trackers, Robotic Reference Frame?

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 NavLock Trackers, Robotic Reference Frame?

The FDA product code for NavLock Trackers, Robotic Reference Frame 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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