de9112d8-7aac-4776-8447-9da5423599e8UpdatePublished72024-09-022015-10-24In Commercial Distribution00821925017405PrimaryGS1Gyrus ACMI140962007198742Gyrus ACMI, LLC1SHEA PORP PROSTHESIS DENSE HYDROXYLAPATITE CAP FLUOROPLASTIC SHAFT falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse1(800)262-3540xxx@xxx.xxxK86444400035674Ossicular prosthesis, totalA sterile device intended to be implanted for the total functional reconstruction of the ossicular chain (mallues, incus, and stapes bones) to facilitate the conduction of sound waves from the tympanic membrane to the inner ear. It is designed to treat conductive hearing loss from traumatic or surgical injury, otosclerosis, congenital fixation of the stapes, or chronic middle ear disease. The device is typically in the form of a tube made of polymers.trueActiveETAReplacement, Ossicular Prosthesis, Totaltruefalse