Name: Predicase
Price: 199 USD

K-number	K152604
Device name	KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set
Applicant	Medtronic Sofamor Danek USA, Incorporated
Product code	PML
Device class	Class II
Decision date	Jan 6, 2016
Decision	Substantially Equivalent
Regulation	888.3027

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Source

View the full FDA submission: accessdata.fda.gov

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KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set

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