Xtant Medical wins FDA nod for Xsert lumbar implant

Xtant Medical (NYSE:XTNT) said today that it won 510(k) clearance from the FDA for its Xsert lumbar expandable interbody spine implant.
The device is designed for lumbar fusion at 1 or 2 levels and is also cleared for use with autograft or autologous bone grafts including Belgrade, Mont.-based Xtant’s 3Demin and patented OsteoSponge allografts.
“We are very pleased to have received clearance for Xsert. This system allows the surgeon to implant the cage in a tighter corridor and then expand the device according to the patient’s anatomy,” director Dr. David Kirschman said in prepared remarks. “With the clearance of allograft use with Xsert, Xtant Medical further expands combined device and biologic solutions for surgeons and their patients.”
Xtant said it plans to make the Xsert available in an initial product release in mid-2017. The company is on a roll this month, raising $3.8 million in an offering and landing FDA clearance for its Irix-C cervical cage.
In July, Xtant Medical said it was expanding its Belgrade, Mont. tissue processing facility to include 7 new processing rooms. The company said the addition will more than double it’s capacity of processing rooms which are available for production.
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Source: Mass Device - November 23, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Spinal Xtant Medical Source Type: news