Name: Predicase
Price: 199 USD

K-number	K122463
Device name	APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W
Applicant	Cayenne Medical, Inc.
Product code	MBI
Device class	Class II
Decision date	Oct 11, 2012
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W

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