FDA.reportPublic FDA data

N/A

Primary DI
00763000913731
Brand
N/A
Company
MEDTRONIC XOMED, INC.
Model
1160000
Device description
PROSTHESIS 1160000 TI PARTIAL RND 2MM
Published
2025-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETAREPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
ETBPROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETAReplacement, Ossicular Prosthesis, TotalEar, Nose, Throat2
ETBProsthesis, Partial Ossicular ReplacementEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002897000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002897000TITANIUM MIDDLE EAR PROSTHESESXomed, Inc.2000-10-11ETB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000913731PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000913731007630009137317630009137310763000913731

GMDN Terms#

Term, Definition table
TermDefinition
Ossicular prosthesis, partialA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835465063
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150064069ApexCut187BL40002026-04-25
00199150064076ApexCut187BL4000L2026-04-25
00199150064083ApexCut187BL40122026-04-25
00199150064090ApexCut187BL40402026-04-25
00199150064106ApexCut187BL40602026-04-25
00763000945640ApexCut187BL29002026-04-25
00763000945657ApexCut187BL35002026-04-25
00763000945718ApexCut187BL35122026-04-25
00763000945732ApexCut187BL35402026-04-25
00763000945756ApexCut187BL29602026-04-24
00763000945763ApexCut187BL35602026-04-25
00763000945787ApexCut187BL29752026-04-25
00763000945794ApexCut187BL35902026-04-25
00763000945800ApexCut187BL351202026-04-25
20643169782666NIM Trivantage®82297392016-11-12
20763000041544NIM TriVantage®82297392020-02-29
00763000033972NIM TriVantage®82297092020-02-15
20681490055158Merocel®22185352017-10-16
00643169782617NIM Trivantage®82297092016-11-12
00613994176547Reuter10103012015-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00844505010269TITANIUM/FLUOROPLASTIC PISTONGrace Medical, Inc.ETB2026-02-03
00844505014526GRACE PISTONGrace Medical, Inc.ETB2026-01-07
00844505014533GRACE PISTONGrace Medical, Inc.ETB2026-01-07
00844505014540GRACE PISTONGrace Medical, Inc.ETB2026-01-07
00844505014502TITANIUM PISTONGrace Medical, Inc.ETB2025-09-18
00844505014687GRACE MEDICAL FLUOROPLASTIC PISTONGrace Medical, Inc.ETB2025-09-18
00844505014489ECLIPSE PISTONGrace Medical, Inc.ETB2025-08-05
00844505014519TITANIUM PISTONGrace Medical, Inc.ETB2025-08-05
00844505014564GRACE MEDICAL FLUOROPLASTIC PISTONGrace Medical, Inc.ETB2025-08-05
00844505014670GRACE MEDICAL FLUOROPLASTIC PISTONGrace Medical, Inc.ETB2025-08-05
00844505014663OFFSET TITANIUM WILDCAT ALTOGrace Medical, Inc.ETA2025-07-17
00844505014649NYTEBYTEGrace Medical, Inc.ETB2025-07-02
00763000913489N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913496BojrabMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913502Causse/PolycelMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913519Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913526Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913533Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913540Causse/Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913557Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913564Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913571Causse/VincentMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913595Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913601Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913625N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913632N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913649N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913656N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913663SilversteinMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913717Sheehy/PolycelMEDTRONIC XOMED, INC.ETA2025-06-23