K-number	K192416
Device name	BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System
Applicant	Zimmer GmbH
Product code	LZO
Device class	Class II
Decision date	Oct 1, 2019
Decision	Substantially Equivalent
Regulation	888.3353

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Source

View the full FDA submission: accessdata.fda.gov

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BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System

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