334245c5-027a-4b1b-b51a-f6346e131778UpdatePublished22024-06-102021-11-072023-12-06Not in Commercial Distribution00763000034412PrimaryGS1Flex H/A®0520835465063MEDTRONIC XOMED, INC.1PROSTHESIS 0520 FLEX H/A OFF TOTAL 4MMfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseMR Conditionaltruefalse+1(800)633-8766Corporate.UDI@medtronic.comK90423900035674Ossicular 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, TOTALLengthDevice Size Text, specifyHead Diameter = 4 mmDevice Size Text, specifyShaft Diameter = 1 mmtruefalse