CAMBER SPINE TECHNOLOGIES RECEIVES FDA CLEARANCE FOR ENZA® ZERO PROFILE ALIF DEVICE: 510(K) CLEARANCE MARKS CAMBER’S EIGHTH SPINAL PRODUCT LINE TO MARKET
Camber Spine Technologies announces that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ENZA® Zero Profile Anterior Interbody Fusion (ALIF) system, a unique, minimally invasive interbody fusion device providing integrated fixation. This clearance marks Camber’s eighth line of spinal implant systems to be released in the US market. The ENZA® Zero Profile ALIF system is intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. The system is intended for use with bone graft and with supplemental fixation systems. The ENZA™ bladed stabilization system, utilizes a simple, one step insertion and fixation method through a minimally invasive approach to achieve interbody fusion.
"We are pleased to receive 510(k) clearance for the Enza system, the latest addition to Camber's product offerings in spine stabilization. This important milestone marks the beginning of a year in which we hope to launch several differentiated technologies and continue to expand our presence to new geographies. Camber's mission is to deliver surgeon inspired technologies to the patient."
-Daniel A. Pontecorvo, CEO Camber Spine Technologies
The ENZA® product was developed under a collaborative agreement with the Institute for Musculoskeletal Science & Education (IMSE), an independent, full-service product development and engineering services company enabling medical device companies to expedite the commercialization of their technologies.