K-number	K200763
Device name	Osteo-site Vertebral Balloon
Applicant	Izi Medical
Product code	HRX
Device class	Class II
Decision date	Aug 12, 2020
Decision	Substantially Equivalent
Regulation	888.1100

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Source

View the full FDA submission: accessdata.fda.gov

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Osteo-site Vertebral Balloon

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