K-number	K200491
Device name	Bfix Orthopedic External Fixator Systems
Applicant	Aike (Shanghai) Medical Instrument Co., Ltd.
Product code	KTT
Device class	Class II
Decision date	Jan 5, 2021
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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Bfix Orthopedic External Fixator Systems

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