Strategic Orthopaedic-related 510(k)s issued in February 2016

By Julie A. Vetalice

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 February 2016 include: C-VBR (Cardinal Spine), Lateral Interbody System (Cogent Spine), M-Fix Acromioclavicular Device (Coracoid Solutions*), Extremity Plate System (Epic Extremity), Winch Kyphoplasty Gauge (G21), MiniARS Screws (Overmed*), Irene Locking Compression Plate (Tianjin Zhengtian Medical Instrument*), trauma Screw (Tyber Medical), Comprehensive SRS/Nexel Elbow (Zimmer Biomet)

Tags: 510(k) Clearance, Regulatory