K-number	K132788
Device name	MYSPINE PEDICLE SCREW PLACEMENT GUIDES
Applicant	Medacta International
Product code	MNI
Device class	Class II
Decision date	May 23, 2014
Decision	Substantially Equivalent
Regulation	888.3070

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Source

View the full FDA submission: accessdata.fda.gov

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MYSPINE PEDICLE SCREW PLACEMENT GUIDES

Everything you need for a 510(k) submission. Nothing you don't.