K-number	K202065
Device name	DOLOMITE Anterior Cervical Stabilization System
Applicant	Astura Medical, LLC
Product code	OVE
Device class	Class II
Decision date	Oct 26, 2020
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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DOLOMITE Anterior Cervical Stabilization System

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