Zavation receives FDA approval for new spinal fusion device — 3 insights

Surface Technology

Zavation received 510(k) clearance from the FDA to market its Ti3Z Interbody System for spinal fusions.

Three insights:

1. The Ti3Z Interbody System is to be used at either one or two levels in the lumbar spine.

2. The device is intended to treat degenerative disc disease with up to Grade I spondylolisthesis after patients have had six months of failed non-operative treatment.

3. The titanium implants have an internal porous structure and an external solid surface developed to engage with the vertebral body end plates.

"The interior lattice structure promotes osseointegration and optimal elasticity, while the external edges of the implant maintains mechanical stability," said Jeffrey Johnson, CEO of Zavation.

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