K-number	K173380
Device name	b-ONE® Total Hip System
Applicant	B-One Ortho, Corp.
Product code	LZO
Device class	Class II
Decision date	Aug 30, 2018
Decision	Substantially Equivalent
Regulation	888.3353

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Source

View the full FDA submission: accessdata.fda.gov

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b-ONE® Total Hip System

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