Name: Predicase
Price: 199 USD

K-number	K191148
Device name	Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set
Applicant	Medtronic Sofamor Danek USA, Inc.
Product code	PML
Device class	Class II
Decision date	Sep 12, 2019
Decision	Substantially Equivalent
Regulation	888.3027

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set

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Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set