c018a880-fa1e-4f94-8afe-88078c1bd819UpdatePublished72024-09-022015-10-24In Commercial Distribution00821925019232PrimaryGS1GYRUS ACMI, INC143007007198742Gyrus ACMI, LLC1VOCOM SHIM 0 MM OFFSET DENSE HYDROXYLAPATITE falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse1(800)262-3540xxx@xxx.xxxK97431100060859Larynx prosthesisA sterile implantable device intended to replace the larynx to provide normal functionality (i.e., breathing, swallowing, and vocalization) following laryngectomy, usually as a treatment for cancer. It consists of a permanently implanted metal (e.g., titanium) tube, with a temporary silicone tube extension initially implanted to facilitate alignment and tissue integration while the airway is maintained with a tracheostoma. Initially a cap occludes the proximal end of the prosthesis, which is later replaced by a valve-like device; the prosthesis is designed to function without a tracheostoma.trueActiveKHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)truefalse