K-number	K241995
Device name	HyperFlex Bunion Correction System
Applicant	Footbridge Medical
Product code	HRS
Device class	Class II
Decision date	Nov 26, 2024
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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HyperFlex Bunion Correction System

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HyperFlex Bunion Correction System