Name: Predicase
Price: 199 USD

K-number	K183196
Device name	Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker
Applicant	Stryker Corporation
Product code	OLO
Device class	Class II
Decision date	Feb 14, 2019
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 SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker

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