Strategic orthopaedic-related 510(k)s issued in December 2015 include:Â Fusion Implant System (Bio2 Technologies), Spinal Fixation System (Changzhou Dingjian Medical), Metallic Intramedullary Nail (Changzhou Waston Medical), Latitude-C Cervical Interbody Spacer (DeGen Medical), V-Steady and V-Fast Bone Cements (G21), Firefly Pedicle Screw Navigational Guide (Mighty Oak Medical), Apex Revision Knee (OMNIlife sciences), Remedy Shoulder Spacer (Osteoremedies), Internal Joint Stabilizer, Elbow (Skeletal Dynamics)Â
Jan 13, 2016