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Reimbursement / Regulatory

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

Hammertoe Correction System (Additive Orthopaedics*); Optimized Positioning System/OPS (Corin); FitRite Total Hip Arthroplasty (Excera Orthopedics); Subtalar Implant System (Life Spine/Centric Medical); dynaMX Nitinol Compression Screw (Mx Orthopedics); Spinal Jaxx Interbody Fusion Device (Neuropro Spinal Jaxx*); Care Brand Locking Bone Plate and Screw (Orthocare*); Orthobutton CL (Riverpoint Medical*); ZUK Select Knee (Smith & Nephew)

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

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