K-number	K201157
Device name	Prime BIOFOAM® Multi-Hole Shells
Applicant	Microport Orthopedics, Inc.
Product code	MBL
Device class	Class II
Decision date	Aug 24, 2021
Decision	Substantially Equivalent
Regulation	888.3358

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Source

View the full FDA submission: accessdata.fda.gov

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Prime BIOFOAM® Multi-Hole Shells

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