8e1d817b-97d0-423e-a405-e15061c7f6a6UpdatePublished52020-03-232016-10-10In Commercial DistributionB167100300100PrimaryHIBCCTALOSĀ® IBF100-300-10182698477MEDITECH SPINE, LLC1falsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK090707000K15078800044759General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.falseActiveMAXIntervertebral fusion device with bone graft, lumbarfalsetrueMoist Heat or Steam Sterilization