Camber Spine Technologies receives FDA 510(k) clearance for MIS ALIF system
Camber Spine Technologies recently received 510(k) FDA clearance for the ENZA Zero Profile anterior lumbar interbody fusion system, a minimally invasive device which offers integrated fixation.
The anterior lumbar interbody fusion (ALIF) device is intended for patients with degenerative disc disease at one or two contiguous levels from L2 to S1. The ENZA Zero Profile is also designed to be used with bone graft and other supplemental fixation systems and uses a one-step insertion and fixation method with a minimally invasive surgery (MIS) approach, according to a company press release.
Daniel A. Pontecorvo
“We are pleased to received 510(k) clearance for the ENZA system, the latest addition to Camber’s product offerings in spine stabilization,” Daniel A. Pontecorvo, chief executive officer of Camber Spine Technologies, said in the release. “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.”
In July, Camber announced the first implantation of the ENZA MIS Zero profile ALIF device occurred during a two-level lumbar surgery done at L4-5 and L5-S1 that was performed at Kennedy University Hospital, in Washington Township, N.J.