Name: Predicase
Price: 199 USD

K-number	K161081
Device name	SeaSpine Shoreline ACS - Anterior Cervical Standalone System
Applicant	SeaSpine Orthopedics Corporation
Product code	OVE
Device class	Class II
Decision date	Sep 14, 2016
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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SeaSpine Shoreline ACS - Anterior Cervical Standalone System

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