510(k) K231002

Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) by Suzhou Endophix Co., Ltd. — Product Code MBI

K231002 is an FDA 510(k) premarket notification submitted by Suzhou Endophix Co., Ltd. for the device "Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)". The FDA issued a decision of Substantially Equivalent on June 7, 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.