ed9e75d5-f33d-47d1-a277-3c2a59ed01d9UpdatePublished42021-06-032015-05-26In Commercial DistributionM697X06005460Direct MarkingHIBCCM697X06005461PrimaryHIBCCAxle Interspinous Fusion SystemX060-0546081224143Xtant Medical Holdings, Inc.1Plate Sizer 31mm AssyfalsetruefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse47127Lumbar 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.falseActiveHWTTEMPLATELengthfalsetrueMoist Heat or Steam Sterilization