FDA.report

Ossicular prosthesis, total

Definition
A 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.
GUDID devices
413
Last updated
2025-07-25 16:46:48

Related Product Codes

CodeDeviceSpecialtyClassDevices
ETAReplacement, Ossicular Prosthesis, TotalEar, Nose, Throat2364
ETBProsthesis, Partial Ossicular ReplacementEar, Nose, Throat232
LBMPorous Polyethylene Ossicular ReplacementEar, Nose, Throat28
LBNReplacement, Total Ossicular, Prosthesis, Porous, PolyethyleneEar, Nose, Throat28
LXHOrthopedic Manual Surgical InstrumentOrthopedic11

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00844505014663OFFSET TITANIUM WILDCAT ALTOGrace Medical, Inc.6232025-07-17
00763000913489N/AMEDTRONIC XOMED, INC.03632025-06-23
00763000913496BojrabMEDTRONIC XOMED, INC.05062025-06-23
00763000913502Causse/PolycelMEDTRONIC XOMED, INC.05182025-06-23
00763000913519Flex H/AMEDTRONIC XOMED, INC.05232025-06-23
00763000913533Flex H/AMEDTRONIC XOMED, INC.05252025-06-23
00763000913557Flex H/AMEDTRONIC XOMED, INC.05302025-06-23
00763000913649N/AMEDTRONIC XOMED, INC.11120912025-06-23
00763000913687Brackmann/PolycelMEDTRONIC XOMED, INC.11563032025-06-23
00763000913724Sheehy/PolycelMEDTRONIC XOMED, INC.11563632025-06-23
00763000033385HA/C Polycel® Brackmann TotalMEDTRONIC XOMED, INC.11123032024-05-12
00763000034849Sheehy HA/C Polycel® T.O.P.MEDTRONIC XOMED, INC.11123632024-05-12
08800043934704N/ATDM Co., Ltd.PMI-0202024-04-03
00844505013666CENTERED ALTO TOTAL Grace Medical, Inc.605-M12021-12-10
00763000033293Wiet / Flex H/A®MEDTRONIC XOMED, INC.05152021-11-07
00763000033323Flex H/A®MEDTRONIC XOMED, INC.05902021-11-07
00763000033330N/AMEDTRONIC XOMED, INC.11120852021-11-07
00763000033347Moretz / Polycel®MEDTRONIC XOMED, INC.11121802021-11-07
00763000033361CausseMEDTRONIC XOMED, INC.11121922021-11-07
00763000034214BojrabMEDTRONIC XOMED, INC.03062021-11-07
00763000034221BojrabMEDTRONIC XOMED, INC.03082021-11-07
00763000034238CausseMEDTRONIC XOMED, INC.03212021-11-07
00763000034252RobinsonMEDTRONIC XOMED, INC.03402021-11-07
00763000034269RobinsonMEDTRONIC XOMED, INC.03412021-11-07
00763000034276RobinsonMEDTRONIC XOMED, INC.03422021-11-07
00763000034283RobinsonMEDTRONIC XOMED, INC.03432021-11-07
00763000034290N/AMEDTRONIC XOMED, INC.03632021-11-07
00763000034337Flex H/A®MEDTRONIC XOMED, INC.05002021-11-07
00763000034344Flex H/A®MEDTRONIC XOMED, INC.05012021-11-07
00763000034351CampbellMEDTRONIC XOMED, INC.05052021-11-07
00763000034368BojrabMEDTRONIC XOMED, INC.05062021-11-07
00763000034375BojrabMEDTRONIC XOMED, INC.05072021-11-07
00763000034382Garcia-Ibanez / Flex H/A®MEDTRONIC XOMED, INC.05082021-11-07
00763000034399Flex H/A®MEDTRONIC XOMED, INC.05102021-11-07
00763000034405Causse / Flex H/A®MEDTRONIC XOMED, INC.05182021-11-07
00763000034412Flex H/A®MEDTRONIC XOMED, INC.05202021-11-07
00763000034429Flex H/A®MEDTRONIC XOMED, INC.05232021-11-07
00763000034436Causse / Flex H/A®MEDTRONIC XOMED, INC.05252021-11-07
00763000034450Causse / Flex H/A®MEDTRONIC XOMED, INC.05272021-11-07
00763000034474Causse / Flex H/A®MEDTRONIC XOMED, INC.05292021-11-07
00763000034481Lesinski / Flex H/A®MEDTRONIC XOMED, INC.05302021-11-07
00763000034504Flex H/A®MEDTRONIC XOMED, INC.05402021-11-07
00763000034528Causse/VincentMEDTRONIC XOMED, INC.054212021-11-07
00763000034566Millen / Flex H/A®MEDTRONIC XOMED, INC.05652021-11-07
00763000034641N/AMEDTRONIC XOMED, INC.11120452021-11-07
00763000034658N/AMEDTRONIC XOMED, INC.11120502021-11-07
00763000034719N/AMEDTRONIC XOMED, INC.11120912021-11-07
00763000034726N/AMEDTRONIC XOMED, INC.11120922021-11-07
00763000034740N/AMEDTRONIC XOMED, INC.11120962021-11-07
00763000034788CausseMEDTRONIC XOMED, INC.11121902021-11-07
00763000034795CausseMEDTRONIC XOMED, INC.11121952021-11-07
00763000035358CausseMEDTRONIC XOMED, INC.11562412021-11-07
00763000035372Moretz / Polycel®MEDTRONIC XOMED, INC.11562982021-11-07
00763000035389Brackmann / Polycel®MEDTRONIC XOMED, INC.11563032021-11-07
00763000035396Austin / Polycel®MEDTRONIC XOMED, INC.11563052021-11-07
00763000035402Fisch / Polycel®MEDTRONIC XOMED, INC.11563072021-11-07
00763000035464Sheehy / Polycel®MEDTRONIC XOMED, INC.11563632021-11-07
00763000035471Moretz / Polycel®MEDTRONIC XOMED, INC.11563722021-11-07
00763000036195Flex H/A®MEDTRONIC XOMED, INC.11500002021-11-07
00763000036201Flex H/A®MEDTRONIC XOMED, INC.11500012021-11-07
00763000036430Vincent Flex H/A®MEDTRONIC XOMED, INC.11500502021-11-07
00763000036508BojrabMEDTRONIC XOMED, INC.03852021-11-07
00763000038427N/AMEDTRONIC XOMED, INC.03002021-11-07
00844505013673HA LITE ALTOGrace Medical, Inc.630-M12021-10-05
00763000035310N/AMEDTRONIC XOMED, INC.11562102021-06-17
00763000035334N/AMEDTRONIC XOMED, INC.11562122021-06-17
00763000035341N/AMEDTRONIC XOMED, INC.11562132021-06-17
00763000039806N/AMEDTRONIC XOMED, INC.11562142021-06-17
00844505013017MORETZ ALTO HA, LEFTGrace Medical, Inc.612-001L2021-02-08
00844505013246BOJRAB TOTALGrace Medical, Inc.625-M12021-02-08
00844505013253OFFSET ALTO TOTAL Grace Medical, Inc.600-M12021-02-08
00844505013260ALTO TOTALGrace Medical, Inc.600-M22021-02-08
00844505013277MORETZ ALTO HA, RIGHTGrace Medical, Inc.612-002R2021-02-08
00844505012959SATALOFF ALTO TOTALGrace Medical, Inc.6242021-01-15
00844505012973BOJRAB ALTO TOTALGrace Medical, Inc.6252021-01-15
00844505012980MORETZ HA DELTA MINI HEAD ALTO TOTALGrace Medical, Inc.6472021-01-15
00844505013475BOJRAB ALTO TOTAL W/INTEGRATED SHOEGrace Medical, Inc.625B2021-01-15
00844505013482DORNHOFFER ALTO TOTALGrace Medical, Inc.6352021-01-15
00844505013499GLUTH ALTO TOTAL Grace Medical, Inc.6482021-01-15
00844505012775HABERMAN ALTO TOTAL ROUND HEADGrace Medical, Inc.6082021-01-08