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Strategic Orthopaedic-related 510(k)s Issued in September 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 September 2015 include: Intervertebral Body Fusion Device (Ackermann Instrumente); Intramedullary Nailing Systems (GPC Medical); Synthetic Bone Graft (Orthogem); Polyscrew Pedicle Fixation System (Senecka Spine*); Pedicle Screw System (Suzhou Gemmed Medical Instrument*); Bluefin Interbody System (Tides Medical*); Cervical Interbody Fusion Device (Vertera Spine*); Secure-Loop Suture (Xiros

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