b9232f89-8a83-4998-af4e-c7857f5d7cc2UpdatePublished42018-07-062016-04-15In Commercial Distribution00190361016977PrimaryGS1FacetFuse®01-00009-SW4545002003243SPINEFRONTIER, INC.1FacetFuse Screw, Small Washer Assy, Full Thread, 4.5 x 45mmtruefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(866)914-7717customerservice@spinefrontier.comK07142000037272Trans-facet-screw internal spinal fixation system, sterileA sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.trueActiveMRWSYSTEM, FACET SCREW SPINAL DEVICELengthOuter DiameterfalsetrueMoist Heat or Steam Sterilization