00be9f3e-8f66-4382-849d-4acb9e2980d9UpdatePublished72025-07-142015-08-31In Commercial Distribution00844856002012PrimaryGS1Zodiac62005602465783ALPHATEC SPINE, INC.1TI STANDARD SET SCREWtruefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(760)431-9286Regulatory@alphatecspine.comK10068500065553Spinal bone set screwA small, implantable, non-bioabsorbable disc, threaded on its outside surface, intended to be threaded into the internal proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).trueActiveKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALMNHOrthosis, spondylolisthesis spinal fixationMNIORTHOSIS, SPINAL PEDICLE FIXATIONfalsetrueMoist Heat or Steam Sterilization