K-number	K210122
Device name	Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)
Applicant	Osteonic Co., Ltd.
Product code	MAI
Device class	Class II
Decision date	Aug 27, 2021
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)

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