K-number	K180263
Device name	EcoFit Vit E Acetabular System
Applicant	Implantcast GmbH
Product code	LZO
Device class	Class II
Decision date	Jul 20, 2018
Decision	Substantially Equivalent
Regulation	888.3353

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Source

View the full FDA submission: accessdata.fda.gov

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EcoFit Vit E Acetabular System

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