K-number	K131324
Device name	MAXTORQUE SCREW SYSTEM
Applicant	Orthohelix Surgical Designs, Inc.
Product code	HWC
Device class	Class II
Decision date	May 31, 2013
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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MAXTORQUE SCREW SYSTEM

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