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FDA 510(k)

Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker

K-Number: K183196 · 2019-02-14

ApplicantStryker Corporation
Decision Date2019-02-14
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2019-02-14 under 510(k) number K183196. 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 Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker?

Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker is a medical device that received FDA 510(k) clearance on 2019-02-14. The listed applicant is Stryker Corporation. The 510(k) number is K183196.

When did Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker receive FDA 510(k) clearance?

Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker received FDA 510(k) clearance on 2019-02-14, under 510(k) number K183196.

Who is the listed applicant for Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker?

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

What is the FDA product code for Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker?

The FDA product code for Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask 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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