K-number	K152972
Device name	Amendia Stand-Alone Cervical System
Applicant	Amendia, Inc.
Product code	OVE
Device class	Class II
Decision date	Jan 14, 2016
Decision	Substantially Equivalent
Regulation	888.3080

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View the full FDA submission: accessdata.fda.gov

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Amendia Stand-Alone Cervical System

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