K-number	K212058
Device name	Longeviti ClearFit OTS Cranial Implants
Applicant	Longeviti Neuro Solutions, LLC
Product code	GXN
Device class	Class II
Decision date	Sep 8, 2021
Decision	Substantially Equivalent
Regulation	882.5330

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Source

View the full FDA submission: accessdata.fda.gov

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Longeviti ClearFit OTS Cranial Implants

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Longeviti ClearFit OTS Cranial Implants