Strategic orthopaedic-related 510(k)s issued in April 2016 include: Olympic Posterior Spinal Fixation System (Astura Medical); Revival Modular Revision Hip Stem (Corin); Internal Bone Staple, Bicortical Fixation Screw & Washer Nut System (First Ray*); G3 Active Plate Small Fragment System (Genesis Fracture Care); Maxigen Bone Void Filler (Hans Biomed); Osteopal Plus Bone Cement (Heraeus); Pedicle Screw System (icotec); Revolution Spinal Fixation System (Intelligent Implant); Glenoid Positioning System (Materialise); Ultra Telescope (Olympus Winter); White Pearl Preferred Angle Anterior Cervical Plate (Osseus Fusion); Starfuse Interphalangeal Pin, Osteobullet Compression Screw (Phalanx Innovations*) (View the full list of orthopaedic 510(k)s for April 2016) 

OrthoPediatrics received Japan regulatory clearance for RESPONSE™ Spine for use in pediatric and adult patients. The product will be distributed regionally through an exclusive agreement with Robert Reid. 

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