SeaSpine Receives FDA 510(k) Clearance for Shoreline ACS System

SeaSpine received FDA 510(k) clearance to market the Shoreline™ ACS Anterior Cervical Standalone system, featuring TruProfile™ technology. Initial cases will occur in limited launch over comings months, while full commercial launch is slated for 1H17.

Shoreline offers a full complement of zero and low-profile plating options, as 10 degree lordotic implants. The TruProfile low profile plate is designed to minimize cephalad/caudal encroachment onto vertebral bodies and maximize the distance from adjacent disc spaces.

Shoreline incorporates SPNE’s NanoMetalene® surface technology, comprising titanium molecularly bonded to a PEEK-OPTIMA® polymer from INVIBIO.

Source: SeaSpine