K-number	K221142
Device name	Kyphoplasty Balloon System
Applicant	OK Medinet Korea Co., Ltd.
Product code	HRX
Device class	Class II
Decision date	Apr 21, 2023
Decision	Substantially Equivalent
Regulation	888.1100

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Source

View the full FDA submission: accessdata.fda.gov

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Kyphoplasty Balloon System

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