Xtant Medical Receives FDA Clearance for Xsert Lumbar Expandable Interbody System

By Julie A. Vetalice

Xtant Medical announced FDA 510(k) clearance to market the Xsert™ Lumbar Expandable Interbody System, including an indication to be packed with autograft or allogrant bone, such as Xtant's 3Demin and OsteoSponge.

The Xsert all-titanium device expands in situ and features nanotextured endplate surfaces to encourage osteointegration.

Initial product launch will commence in mid-2017.

Sources: Xtant Medical Holdings, Inc.; ORTHOWORLD Inc.

Product Labels: Lumbar Spine, Spinal Fusion

Tags: 510(k) Clearance, Regulatory