K-number	K140689
Device name	IKNEE DISTAL FEMORAL CUTTING GUIDE
Applicant	Evergreen Orthopedic Research Lab
Product code	OLO
Device class	Class II
Decision date	Aug 22, 2014
Decision	Substantially Equivalent
Regulation	882.4560

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Source

View the full FDA submission: accessdata.fda.gov

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IKNEE DISTAL FEMORAL CUTTING GUIDE

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