K-number	K193497
Device name	Fixone Biocomposite Interference Screw
Applicant	Aju Pharm Co., Ltd.
Product code	HWC
Device class	Class II
Decision date	Jan 5, 2021
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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Fixone Biocomposite Interference Screw

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