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FDA 510(k)

Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker

K-Number: K162929 · 2017-02-22

ApplicantStryker Corporation
Decision Date2017-02-22
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask 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 2017-02-22 under 510(k) number K162929. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker?

Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker is a medical device that received FDA 510(k) clearance on 2017-02-22. The listed applicant is Stryker Corporation. The 510(k) number is K162929.

When did Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker receive FDA 510(k) clearance?

Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker received FDA 510(k) clearance on 2017-02-22, under 510(k) number K162929.

Who is the listed applicant for Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask 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 CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker?

The FDA product code for Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker is HAW.

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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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