Strategic Orthopaedic-related 510(k)s issued in May 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.
Navio Indication for TKA (Blue Belt Technologies), Enza Zero-profile Anterior Interbody Fusion System (Camber Spine), CSR Shoulder System (Catalyst OrthoScience*), Stropp/Single Tunnel Repair of Plantar Plate (CrossRoads Extremity), Cervical Interbody Fusion System (Evolution Spine*), Flip Button Suture Anchor (First Ray), Neofuse HA Enhanced PLIF/TLIF (HT Medical*), HC Spinal System (Hung Chun Bio-S*)
View the full list of orthopaedic 510(k)s for May 2016, here.