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Strategic Orthopaedic-related 510(k)s Issued in November 2015


Each month, ORTHOWORLD examines updates to FDA's orthopaedic-related 510(k) database and highlights those products deemed strategic, defined as a company's first 510(k) clearance, first clearance in a segment that is new to the company, clearance for a type of device not formerly marketed by a company, etc.

In the following list, companies receiving a first orthopaedic-related 510(k) are denoted with an asterisk.

Strategic orthopaedic-related 510(k)s issued in November 2015 include: Avaflex Vertebral Balloon System (Carefusion); Pedicle Fixation System (Changzhou Waston Medical); Lumbar Interbody Fusion System (Integrity Spine); Suture Anchor (Kator*); NET Small and Large Fragment Osteosynthesis Plating System (Narang Medical*); Talon Distalfix Antegrade/Retrograde Femoral Nail (Orthopedic Designs North America); RT2 Trabeculite Titanium Cervical Cage (Rhausler); Pullup Adjustable Juxtacortical Fixation Device (SBM/Sciences for Bio Materials); Libra Pedicle Screw (Spinal Balance*)

View the full list of orthopaedic 510(k)s for November, here.