Name: Predicase
Price: 199 USD

K-number	K182151
Device name	MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate
Applicant	Ctl Medical Corporation
Product code	OVE
Device class	Class II
Decision date	Oct 11, 2018
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate

Everything you need for a 510(k) submission. Nothing you don't.