K-number	K180817
Device name	AERIAL Interspinous Fixation
Applicant	Globus Medical, Inc.
Product code	PEK
Device class	Class II
Decision date	May 21, 2018
Decision	Substantially Equivalent
Regulation	888.3050

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View the full FDA submission: accessdata.fda.gov

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AERIAL Interspinous Fixation

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AERIAL Interspinous Fixation