258754a9-e353-4004-980f-4d16bd38b671NewPublished12025-07-182025-07-10In Commercial Distribution00763000855765PrimaryGS1PYRAMESH® Implant System9051918830350380MEDTRONIC SOFAMOR DANEK, INC.1MESH 9051918 PYRMSH IMPL 19MM AGL 13X18falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)633-8766Corporate.UDI@medtronic.comK183197000K89060100046580Extra-gynaecological surgical mesh, metalA non-bioabsorbable, implantable material (e.g., flat sheet) made from made from a biocompatible metal, with appropriate mechanical characteristics for implantation, intended for an extra-gynaecological tissue repair/reinforcement application(s) to support or protect tissues in reconstructive surgical procedures (e.g., to repair large chest wall defects or large abdominal incisional hernias) and/or orthopaedic procedures (e.g., cranioplasty, femoral reconstruction); it is not primarily intended for dental use. Disposable devices associated with implantation may be supplied with the mesh.trueActiveMQPSpinal vertebral body replacement deviceEZXMesh, surgical, metalfalsetrueMoist Heat or Steam Sterilization