K-number	K181622
Device name	StrataMR guider tool
Applicant	Medtronic Neurosurgery
Product code	JXG
Device class	Class II
Decision date	Oct 1, 2018
Decision	Substantially Equivalent
Regulation	882.5550

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Source

View the full FDA submission: accessdata.fda.gov

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StrataMR guider tool

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