K-number	K221087
Device name	Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
Applicant	Medtronic Navigation, Inc.
Product code	HAW
Device class	Class II
Decision date	Jun 10, 2022
Decision	Substantially Equivalent
Regulation	882.4560

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Source

View the full FDA submission: accessdata.fda.gov

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Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4

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