Name: Predicase
Price: 199 USD

K-number	K143739
Device name	POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA
Applicant	Smith & Nephew, Inc.
Product code	LZO
Device class	Class II
Decision date	Apr 20, 2015
Decision	Substantially Equivalent
Regulation	888.3353

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Source

View the full FDA submission: accessdata.fda.gov

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POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA

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