K-number	K122541
Device name	ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)
Applicant	Orthofix Srl
Product code	KTW
Device class	Class II
Decision date	Sep 20, 2012
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)

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