K-number	K151532
Device name	KYPHON ELEMENT Inflatable Bone Tamp
Applicant	Medtronic, Inc.
Product code	HRX
Device class	Class II
Decision date	Jul 23, 2015
Decision	Substantially Equivalent
Regulation	888.1100

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Source

View the full FDA submission: accessdata.fda.gov

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KYPHON ELEMENT Inflatable Bone Tamp

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