510(k) K222423

Fixone All Suture Anchor by Aju Pharm Co., Ltd. — Product Code MBI

K222423 is an FDA 510(k) premarket notification submitted by Aju Pharm Co., Ltd. for the device "Fixone All Suture Anchor". The FDA issued a decision of Substantially Equivalent on March 23, 2023. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Aju Pharm Co., Ltd. has at least 9 other 510(k) clearances on record.