Name: Predicase
Price: 199 USD

K-number	K162715
Device name	SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene
Applicant	SeaSpine Orthopedics Corporation
Product code	MAX
Device class	Class II
Decision date	Oct 28, 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 Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene

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