K-number	K190598
Device name	CROSSWAY Spinal Access System
Applicant	Globus Medical, Inc.
Product code	HRX
Device class	Class II
Decision date	Apr 5, 2019
Decision	Substantially Equivalent
Regulation	888.1100

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Source

View the full FDA submission: accessdata.fda.gov

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CROSSWAY Spinal Access System

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