b9b335b1-1b63-4d40-872a-d0656455cfa8UpdatePublished52025-07-142018-03-23In Commercial Distribution08809493854655PrimaryGS1MEGA PLUS SPINE SYSTEM93120687941818BK MEDITECH CO.,LTD.1Dual Locking BoltfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK17318000065553Spinal 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).trueActiveNKBThoracolumbosacral Pedicle Screw SystemfalsetrueMoist Heat or Steam Sterilization