Name: Predicase
Price: 199 USD

K-number	K153250
Device name	Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System
Applicant	Renovis Surgical Technologies
Product code	OVE
Device class	Class II
Decision date	Mar 16, 2016
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System

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