Device typeLarynx prosthesis: A 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.
FDA categoryPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Device ID00821925019171
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information