Zavation Medical Receives FDA 510(k) for eZspand Lateral Cage

By Julie A. Vetalice

Zavation Medical Receives FDA 510(k) for eZspand Lateral Cage

Zavation Medical Products was granted FDA 510(k) clearance to market eZspand™ Lateral, an expandable lumbar interbody fusion device.

eZspand Lateral features expandable precision paired with continual expansion to support an optimized fit for each patient. eZspand Lateral does not require secondary locking, minimizing procedural steps. The cage has up to 15° lordosis and the ability to backfill with bone graft. Each implant expands to 6mm from the insertion height to create a large graft window that facilitates fusion.

Zavation eZspand Interbody System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. eZspand Interbody System implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease with up to Grade I spondylolisthesis.

The Zavation eZspand Interbody System implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including the Zavation Spinal System.

Source: Zavation Medical Products

Product Labels: Lumbar Spine, Spinal Fusion

Tags: 510(k) Clearance, Regulatory