Camber Spine Gains FDA Clearance for ENZA-A Titanium ALIF

By Julie A. Vetalice

Camber Spine received FDA 510(k) clearance to market the ENZA™-A Titanium Anterior Lumbar Interbody Fusion system.

ENZA™-A comprises a 3D printed body with a roughened surface and 500 micron-sized pores in the upper and lower faces to support bone ingrowth. Multiple openings can accept a large volume of autogenous bone graft.

Similar to the original ENZA design, ENZA-A features two sharpened anchor plates inside the body that are deployed into adjacent vertebrae to provide fixation. A single inline instrument inserts, deploys and locks the device in place.

Source: Camber Spine, LLP

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory