San Clemente, Calif.-based Vertiflex announced FDA clearances for its Totalis Direct Decompression System and UniVise Spinous Process Fixation System.
The twin regulatory wins, received in Noveber and December respectively, expand the company’s product portfolio for the treatment of lumbar spinal diseases, the company said.
"These regulatory clearances represent important milestones for VertiFlex as we rapidly expand our portfolio of innovative interspinous technologies," president & CEO Earl Fender said in prepared remarks. "This accomplishment highlights the company’s core strengths and fundamental commitment to provide physicians with multiple options to best treat patients in the least invasive methods possible."
The Totalis Direct Decompression System and UniVise Spinous Process Fixation System provides minimally invasive direct decompressions of the lumbar spine.
VertiFlex sold several of its spinal reconstruction products to Exactech Inc in 2010.