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

Q: What is the product code of K162929?

The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.

FDA 510(k) K162929 · Stryker Corporation

Substantially Equivalent

510(k) numberK162929

Submission

Device name: Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker
Applicant: Stryker Corporation
Freiburg Baden-Wurttemberg, DE
Received: October 19, 2016
Decision date: February 22, 2017
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HAW – Neurological Stereotaxic Instrument
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.4560
Specialty: Neurology

Other 510(k)s with product code HAW

510(k)	Device	Applicant	Decision
K253856	Geniant Cranial (Navigated Neurosurgical Positioning Robot)HAW · Traditional	Koh Young Technology, Inc.	09/10/2026SE
K261932	Leksell® Vantage Stereotactic SystemHAW · Traditional	Elekta Solutions AB	08/05/2026SE
K253663	Zeta Navigation SystemHAW · Traditional	Zeta Surgical, Inc.	05/01/2026SE
K253379	Stealth AXiS Cranial clinical applicationHAW · Traditional	Medtronic Navigation, Inc.	03/26/2026SE
K231897	NeuroAlign softwareHAW · Traditional	Medivis, Inc.	10/21/2025SE
K251317	SOLOPASS 2.0 SystemHAW · Traditional	Intravent Medical Partners	09/05/2025SE
K250893	Ball Joint Guide Array (66295)HAW · Traditional	Bayer Medical Care, Inc.	09/04/2025SE
K250505	Ez-FiducialsHAW · Traditional	Phasor Health, LLC	07/09/2025SE
K242575	Stereotaxic Guiding Surgical Devices, NaoTrac SHAW · Traditional	Brain Navi Biotechnology Co., Ltd.	05/23/2025SE
K241327	Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional	Claronav	02/05/2025SE

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Questions and answers

When was Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker cleared by the FDA?

Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker (K162929) received a 510(k) decision of Substantially Equivalent on February 22, 2017, 126 days after the submission was received.

What is the product code of K162929?

The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.