Cardinal Spine Receives FDA 510(k) Clearance for Cervical Vertebral Body Replacement

By Julie A. Vetalice

On behalf of Cardinal Spine, PaxMed International received FDA 510(k) clearance of the C-VBR vertebral body replacement—reportedly the second cervical vertebral body replacement device to be cleared by FDA and the first such device designed with no possibility of reduction in height after surgery.

Source: PaxMed International

 

This clearance marks a milestone for PaxMed International, in that it is the consulting firm’s 180th 510(k) clearance.

 

NuVasive received FDA 510(k) clearance to market the X-Core® Mini Cervical Corpectomy System, reportedly the 1st clearance of a cervical corpectomy cage, in September 2015.

Tags: 510(k) Clearance, Regulatory