K-number	K210390
Device name	Apex 3D Total Ankle Replacement System
Applicant	Paragon 28, Inc.
Product code	HSN
Device class	Class II
Decision date	Mar 6, 2021
Decision	Substantially Equivalent
Regulation	888.3110

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Source

View the full FDA submission: accessdata.fda.gov

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Apex 3D Total Ankle Replacement System

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