Strategic Orthopaedic-related 510(k)s issued in August 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. Additional information on select devices is available via links.

Xycor Expandable Spinal Spacer (Alphatec Spine); Valeo II Interbody Fusion Device (Amedica); Tarsa-Link Standalone Wedge, Hammertoe Correction System (Centric Medical/Life Spine); Universal Spine System (Double Medical Technology); Titan Reverse Shoulder (Integra LifeSciences); Virtu Lumbar Spacer (Met 1 Technologies*); Distal Radius Plating System (Miami Device Solutions); Response BandLoc Spinal Fixation (OrthoPediatrics)

Tags: 510(k) Clearance, Regulatory