K-number	K170444
Device name	PROCOTYL® PRIME Acetabular Cup System
Applicant	Microport Orthopedics, Inc.
Product code	LPH
Device class	Class II
Decision date	Jun 26, 2017
Decision	Substantially Equivalent
Regulation	888.3358

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Source

View the full FDA submission: accessdata.fda.gov

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PROCOTYL® PRIME Acetabular Cup System

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