4ba9ac84-c1c0-4d2c-9c21-f3ce2deaa70fNewPublished12024-10-102024-10-02In Commercial Distribution00190837200558PrimaryGS1ARx175-040183641617Life Spine, Inc.1falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK22034100066948Spinal bone screw head/rod adaptorA small, implantable, non-bioabsorbable device intended to be attached to the top end of a spinal screw (not included) typically to secure/stabilize a rod and/or connector as part of an internal spinal fixation procedure. Also known as a reduction head or tulip, it is typically U-shaped with threads to receive a set screw and/or has a hole to allow the rod and/or connector to pass through; it may also facilitate a degree of motion. It is available in various lengths and is made of metal (e.g., surgical steel, titanium alloy) and/or synthetic polymer materials.trueActiveNKBThoracolumbosacral Pedicle Screw SystemfalsetrueMoist Heat or Steam Sterilization