510(k) K232725

Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor by Suzhou Endophix Co., Ltd. — Product Code MBI

K232725 is an FDA 510(k) premarket notification submitted by Suzhou Endophix Co., Ltd. for the device "Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor". The FDA issued a decision of Substantially Equivalent on November 2, 2023. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Suzhou Endophix Co., Ltd. has at least 3 other 510(k) clearances on record.