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Reimbursement / Regulatory

Strategic orthopaedic-related 510(k)s issued in October 2016 -

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. Additional information on select devices is available via links.

Nanobone SBX Putty (Artoss), LumFix Spinal Fixation System (CG Bio*), Hammertech Fixation System (Fusion Orthopedics*), Eleos Limb Salvage System (Onkos Surgical*), Cavux Cervical Cage (Providence Medical), iNSitu Total Hip (NextStep Arthropedix*/Theken)

View the full list of orthopaedic 510(k)s for October 2016 here.

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