K-number	K220260
Device name	Hercules Syndesmosis Implant System
Applicant	In2bones USA, LLC
Product code	HTN
Device class	Class II
Decision date	Mar 31, 2022
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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Hercules Syndesmosis Implant System

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