K-number	K122814
Device name	GALLEON PEDICLE SCREW SYSTEM
Applicant	Everest Spine, LLC
Product code	MNH
Device class	Class II
Decision date	Dec 3, 2012
Decision	Substantially Equivalent
Regulation	888.3070

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Source

View the full FDA submission: accessdata.fda.gov

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GALLEON PEDICLE SCREW SYSTEM

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