K-number	K240834
Device name	EcoFit® short stem cementless cpTi
Applicant	Implantcast GmbH
Product code	LZO
Device class	Class II
Decision date	Jun 3, 2024
Decision	Substantially Equivalent
Regulation	888.3353

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Source

View the full FDA submission: accessdata.fda.gov

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EcoFit® short stem cementless cpTi

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