K-number	K131343
Device name	REFORM PEDICLE SCREW SYSTEM
Applicant	Spinal USA
Product code	MNI
Device class	Class II
Decision date	Jul 24, 2013
Decision	Substantially Equivalent
Regulation	888.3070

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Source

View the full FDA submission: accessdata.fda.gov

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REFORM PEDICLE SCREW SYSTEM

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