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Reimbursement / Regulatory

Strategic Orthopaedic-related 510(k)s issued in September 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.

Bone Wedge System (Additive Orthopaedics); Portage System - Arthroscope (Baylis Medical); Spinal Fixation System (Canwell Medical); Interform Cervical Interbody Cage (Next Orthosurgical); MAGEC Spinal Bracing and Distraction System (NuVasive Specialized Orthopedics*); K-Wire and Pin System (Syntorr*); mi-eye 2 Arthroscope (Trice Medical)

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

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