510(k) K230946

Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L by Trax Surgical — Product Code HWC

K230946 is an FDA 510(k) premarket notification submitted by Trax Surgical for the device "Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L". The FDA issued a decision of Substantially Equivalent on September 15, 2023. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Trax Surgical has at least 2 other 510(k) clearances on record.