eb30e713-bc15-4305-8df4-5026fb2acbe0UpdatePublished32024-09-232018-10-26In Commercial DistributionM697X06015201PrimaryHIBCCM697X06015200Direct MarkingHIBCCAxle Interspinous Fusion SystemX060-1520081224143Xtant Medical Holdings, Inc.1PLIERS ALL-IN-ONE, INSERTER/COMPRESSOR, ASSEMBLYfalsetruefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(888)886-9354cs@xtantmedical.com47127Lumbar interspinous decompression instrument set, reusableA collection of surgical instruments and devices intended to be used for the implantation of an interspinous process decompression (IPD) implant that is inserted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures; this is typically to treat a patient suffering from symptomatic degenerative lumbar spinal stenosis (DLSS). It typically consists of a tray, dedicated dilators, a sizing instrument, a spacer (the implant) insertion instrument, implant holders, and a torque-limiting screwdriver. This is a reusable device.falseActiveHTCPliers, SurgicalfalsetrueMoist Heat or Steam Sterilization