K-number	K191243
Device name	HEDRON Cervical Spacers
Applicant	Globus Medical, Inc.
Product code	ODP
Device class	Class II
Decision date	Sep 17, 2019
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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HEDRON Cervical Spacers

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