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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 the device name listed in this FDA 510(k) record. The listed applicant is Orthofix, Inc.. It received FDA 510(k) clearance on 2017-03-13 under 510(k) 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. The listed applicant is Orthofix, Inc.. The 510(k) number is K162921.

When did Navigated Instrument System receive FDA 510(k) clearance?

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

Who is the listed applicant for Navigated Instrument System?

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

What is the FDA product code for Navigated Instrument System?

The FDA product code for Navigated Instrument System is OLO.

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NCT07282067Orthofix PhysioStim PEMF Ankle Fusion RetrospectiveACTIVE_NOT_RECRUITING

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Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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