K-number	K201519
Device name	PROFEMUR® GLADIATOR® Cemented Classic Stem
Applicant	Microport Orthopedics, Inc.
Product code	JDI
Device class	Class II
Decision date	Dec 10, 2020
Decision	Substantially Equivalent
Regulation	888.3350

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Source

View the full FDA submission: accessdata.fda.gov

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PROFEMUR® GLADIATOR® Cemented Classic Stem

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