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FDA 510(k)

Navigated Instrument System

K-Number: K162921 · 2017-03-13

ApplicantOrthofix, Inc.
Decision Date2017-03-13
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Navigated Instrument System is a medical device manufactured by Orthofix, Inc.. It received FDA 510(k) clearance on 2017-03-13 under approval number K162921. 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 Navigated Instrument System?

Navigated Instrument System is a medical device that received FDA 510(k) clearance on 2017-03-13. It is manufactured by Orthofix, Inc.. The 510(k) number is K162921.

When was Navigated Instrument System approved by the FDA?

Navigated Instrument System received FDA 510(k) clearance on 2017-03-13, under approval number K162921.

What company makes Navigated Instrument System?

Navigated Instrument System is manufactured by Orthofix, Inc..

What is the FDA product code for Navigated Instrument System?

The FDA product code for Navigated Instrument System 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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