FDA.report

Ossicular prosthesis, partial

Definition
A sterile device intended to be implanted for the functional reconstruction of segments of the ossicular chain (mallues, incus, and/or 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 metal [e.g., stainless steel, titanium (Ti)], polymers, or a combination of these materials.
GUDID devices
1,084
Last updated
2026-02-11 15:06:57

Related Product Codes

CodeDeviceSpecialtyClassDevices
ETBProsthesis, Partial Ossicular ReplacementEar, Nose, Throat2820
ETAReplacement, Ossicular Prosthesis, TotalEar, Nose, Throat2250
LBMPorous Polyethylene Ossicular ReplacementEar, Nose, Throat27
LTBCyclosporine RadioimmunoassayClinical Chemistry25
LBNReplacement, Total Ossicular, Prosthesis, Porous, PolyethyleneEar, Nose, Throat22

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00844505010269TITANIUM/FLUOROPLASTIC PISTONGrace Medical, Inc.409-6002026-02-03
00844505014526GRACE PISTONGrace Medical, Inc.412-5252026-01-07
00844505014533GRACE PISTONGrace Medical, Inc.412-5502026-01-07
00844505014540GRACE PISTONGrace Medical, Inc.412-5752026-01-07
00844505014502TITANIUM PISTONGrace Medical, Inc.461-5752025-09-18
00844505014687GRACE MEDICAL FLUOROPLASTIC PISTONGrace Medical, Inc.402-5502025-09-18
00844505014489ECLIPSE PISTONGrace Medical, Inc.467-3502025-08-05
00844505014519TITANIUM PISTONGrace Medical, Inc.460-5752025-08-05
00844505014564GRACE MEDICAL FLUOROPLASTIC PISTONGrace Medical, Inc.402-4752025-08-05
00844505014670GRACE MEDICAL FLUOROPLASTIC PISTONGrace Medical, Inc.402-5752025-08-05
00844505014649NYTEBYTEGrace Medical, Inc.650N2025-07-02
00763000309480Causse/PolycelMEDTRONIC XOMED, INC.11563762025-06-23
00763000913526Flex H/AMEDTRONIC XOMED, INC.05242025-06-23
00763000913540Causse/Flex H/AMEDTRONIC XOMED, INC.05262025-06-23
00763000913564Flex H/AMEDTRONIC XOMED, INC.05412025-06-23
00763000913571Causse/VincentMEDTRONIC XOMED, INC.05432025-06-23
00763000913595Flex H/AMEDTRONIC XOMED, INC.05702025-06-23
00763000913601Flex H/AMEDTRONIC XOMED, INC.05802025-06-23
00763000913625N/AMEDTRONIC XOMED, INC.11120752025-06-23
00763000913632N/AMEDTRONIC XOMED, INC.11120902025-06-23
00763000913656N/AMEDTRONIC XOMED, INC.11120952025-06-23
00763000913663SilversteinMEDTRONIC XOMED, INC.11121202025-06-23
00763000913700Austin/PolycelMEDTRONIC XOMED, INC.11563612025-06-23
00763000913717Sheehy/PolycelMEDTRONIC XOMED, INC.11563622025-06-23
00763000913731N/AMEDTRONIC XOMED, INC.11600002025-06-23
00763000913762N/AMEDTRONIC XOMED, INC.03622025-06-23
04048551279441N/AKarl Storz GmbH & Co. KG2275202015-10-09
04048551279458N/AKarl Storz GmbH & Co. KG2275122015-10-09
04048551279465N/AKarl Storz GmbH & Co. KG2275112015-10-09
04048551279472N/AKarl Storz GmbH & Co. KG2275222015-10-09
04048551279489N/AKarl Storz GmbH & Co. KG2275172015-10-09
04048551279496N/AKarl Storz GmbH & Co. KG2275162015-10-09
04048551279502N/AKarl Storz GmbH & Co. KG2275152015-10-09
04048551279540N/AKarl Storz GmbH & Co. KG2275102015-10-09
00821925035478Gyrus ACMIGyrus Acmi, Inc.1407412024-07-25
00763000034832Sheehy HA/C Polycel® P.O.P.MEDTRONIC XOMED, INC.11123622024-05-12
00763000036591Big Easy® PistonMEDTRONIC XOMED, INC.11566112024-05-12
00763000036607Big Easy® PistonMEDTRONIC XOMED, INC.11566122024-05-12
00763000036614Big Easy® PistonMEDTRONIC XOMED, INC.11566132024-05-12
00763000036621Big Easy® PistonMEDTRONIC XOMED, INC.11566212024-05-12
00763000036638Big Easy® PistonMEDTRONIC XOMED, INC.11566222024-05-12
00763000036645Big Easy® PistonMEDTRONIC XOMED, INC.11566232024-05-12
00763000043179Brackmann HA/C Polycel® PartialMEDTRONIC XOMED, INC.11123052024-05-12
00763000033286LesinskiMEDTRONIC XOMED, INC.04272023-12-08
00763000034313LesinskiMEDTRONIC XOMED, INC.04282023-12-08
00763000034320LesinskiMEDTRONIC XOMED, INC.04292023-12-08
00763000034887House-Type Piston & WireMEDTRONIC XOMED, INC.11170452023-12-08
00763000034979Schuknecht-Type Piston & WireMEDTRONIC XOMED, INC.11281402023-12-08
EHKM10022601CliP Partial Prosthesis TitaniumHeinz Kurz GmbH10022602023-09-29
EHKM10022641CliP Partial Prosthesis TitaniumHeinz Kurz GmbH10022642023-09-29
EHKM10022661CliP Partial Prosthesis TitaniumHeinz Kurz GmbH10022662023-09-29
EHKM10022681CliP Partial Prosthesis TitaniumHeinz Kurz GmbH10022682023-09-29
EHKM10022701CliP Partial Prosthesis TitaniumHeinz Kurz GmbH10022702023-09-29
EHKM10022721CliP Partial Prosthesis TitaniumHeinz Kurz GmbH10022722023-09-29
EHKM10022731CliP Partial Prosthesis TitaniumHeinz Kurz GmbH10022732023-09-29
EHKM10022741CliP Partial Prosthesis TitaniumHeinz Kurz GmbH10022742023-09-29
EHKM10023641CliP Partial FlexiBAL TitaniumHeinz Kurz GmbH10023642023-09-29
EHKM10023661CliP Partial FlexiBAL TitaniumHeinz Kurz GmbH10023662023-09-29
EHKM10023681CliP Partial FlexiBAL TitaniumHeinz Kurz GmbH10023682023-09-29
00844505013130PRECISE CENTERED NYTEBYTE PARTIALGrace Medical, Inc.753-1002023-09-14
00844505013147PRECISE CENTERED NYTEBYTE PARTIALGrace Medical, Inc.753-1252023-09-14
00844505013154PRECISE CENTERED NYTEBYTE PARTIALGrace Medical, Inc.753-1502023-09-14
00844505013161PRECISE CENTERED NYTEBYTE PARTIALGrace Medical, Inc.753-1752023-09-14
00763000036553Big Easy® PistonMEDTRONIC XOMED, INC.11566012023-04-01
00763000036560Big Easy® PistonMEDTRONIC XOMED, INC.11566022023-04-01
00763000036577Big Easy® PistonMEDTRONIC XOMED, INC.11566032023-04-01
00763000036584Big Easy® PistonMEDTRONIC XOMED, INC.11566042023-04-01
00844505013178PRECISE CENTERED NYTEBYTE PARTIALGrace Medical, Inc.753-2002022-09-26
00844505013109DORNHOFFER NYTEBYTE PARTIAL W/WINDOWSGrace Medical, Inc.692-1002022-09-20
00844505013796DORNHOFFER NYTEBYTE PARTIAL W/WINDOWSGrace Medical, Inc.692-1252022-09-20
00844505013802DORNHOFFER NYTEBYTE PARTIAL W/WINDOWSGrace Medical, Inc.692-1502022-09-20
00844505013079CENTERED ALTO NYTEBYTE PARTIALGrace Medical, Inc.655N2022-08-24
00844505013086HA LITE ALTO NYTEBYTE PARTIALGrace Medical, Inc.685N2022-08-24
00844505013093DORNHOFFER ALTO NYTEBYTE PARTIALGrace Medical, Inc.687N2022-08-24
00844505013901PRECISE HA LITE PARTIALGrace Medical, Inc.770-1502022-03-11
00844505013765MIAMI IS COUPLER PARTIAL – SHORTGrace Medical, Inc.7602022-03-07
00844505013772MIAMI IS COUPLER PARTIAL – LONGGrace Medical, Inc.7612022-03-07
00844505013895ECLIPSE PISTONGrace Medical, Inc.464-8002022-03-07
00844505013222DORNHOFFER ALTO PARTIALGrace Medical, Inc.695-M12021-12-10
00844505013680CENTERED ALTO PARTIALGrace Medical, Inc.655-M12021-12-10