K-number	K190526
Device name	High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws
Applicant	CarboFix Orthopedics , Ltd.
Product code	PML
Device class	Class II
Decision date	Sep 19, 2019
Decision	Substantially Equivalent
Regulation	888.3027

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Source

View the full FDA submission: accessdata.fda.gov

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High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws

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