d8e336be-2c3f-4312-b091-dde47ae0751dUpdatePublished52024-11-182016-02-23In Commercial DistributionM697C08000480Direct MarkingHIBCCM697C08000481PrimaryHIBCCIrix-A Lumbar Integrated Fusion SystemC080-0048081224143Xtant Medical Holdings, Inc.1SPECIALTY IRIX A RASP ASSEMBLY 33X26X12 DEG 17mmfalsetruefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(888)886-9354cs@xtantmedical.com35559Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.falseActiveHTRRASPfalsetrueMoist Heat or Steam Sterilization