510(k) K190385

CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System by In2bones USA, LLC — Product Code HRS

K190385 is an FDA 510(k) premarket notification submitted by In2bones USA, LLC for the device "CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System". The FDA issued a decision of Substantially Equivalent on August 8, 2019. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. In2bones USA, LLC has at least 10 other 510(k) clearances on record.