3a9ce94b-2d39-4963-837d-e840ddffe41bUpdatePublished62025-04-242015-09-112024-12-16Not in Commercial DistributionM697X06702011PrimaryHIBCCCertex Spinal Fixation SystemX067-0201081224143Xtant Medical Holdings, Inc.1CERTEX, AXIAL/PARALLEL ROD CONNECTOR, 3.5-3.5 BODYtruefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(888)886-9354cs@xtantmedical.com65114Bone-screw internal spinal fixation system connectorAn implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.trueActiveKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALNKGPosterior cervical screw systemOuter DiameterfalsetrueMoist Heat or Steam Sterilization