K-number	K212391
Device name	MCI-Neuro Fixation System
Applicant	Mci Medical Concept Innovation, Inc.
Product code	GWO
Device class	Class II
Decision date	Oct 21, 2022
Decision	Substantially Equivalent
Regulation	882.5320

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Source

View the full FDA submission: accessdata.fda.gov

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MCI-Neuro Fixation System

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