510(k) K230118

Bony Trauma Extremity System (BTES) Screw Range, NX Nail by Field Orthopaedics Pty, Ltd. — Product Code HWC

K230118 is an FDA 510(k) premarket notification submitted by Field Orthopaedics Pty, Ltd. for the device "Bony Trauma Extremity System (BTES) Screw Range, NX Nail". The FDA issued a decision of Substantially Equivalent on Feb 16, 2023. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Field Orthopaedics Pty, Ltd. has 2 other 510(k) clearances on record.