Precision Spine Receives FDA 510(k) Clearance for ShurFit ACIF 2C System

By Julie A. Vetalice

Precision Spine received FDA 510(k) clearance of its ShurFit® ACIF 2C Anterior Cervical Interbody System.

The device is manufactured from PEEK Optima and coated with titanium and hydroxyapatite to facilitate bone ongrowth during the fusion process.

The announcement closely follows clearance of the AccuFit® Lateral Plate, which features four points of fixation and five sizes matched to the heights of ShurFit LLIF interbody cages.

Sources: Precision Spine, Inc.; ORTHOWORLD Inc.

 

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory