Name: Predicase
Price: 199 USD

K-number	K162929
Device name	Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker
Applicant	Stryker Corporation
Product code	HAW
Device class	Class II
Decision date	Feb 22, 2017
Decision	Substantially Equivalent
Regulation	882.4560

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.