K-number	K212397
Device name	StealthStation S8 Cranial v2.0
Applicant	Medtronic Navigation
Product code	HAW
Device class	Class II
Decision date	Dec 22, 2021
Decision	Substantially Equivalent
Regulation	882.4560

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Source

View the full FDA submission: accessdata.fda.gov

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StealthStation S8 Cranial v2.0

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