FDA.reportPublic FDA data

ENDURANCE

Primary DI
10603295057376
Brand
ENDURANCE
Company
DEPUY ORTHOPAEDICS, INC.
Model
1521-74-000
Catalog number
152174000
Device description
FEMORAL STEM 12/14 TAPER ENDURANCE HIP STEM SIZE 3 300mm LEFT BOWED
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942370000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942370000DEPUY CEMENTED HIP PROSTHESISDepuy, Inc.1994-11-10JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295057376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329505737610603295057376

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) typically designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
080506581
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295553588ATTUNE2999-67-0282999670282026-08-26
10603295553595ATTUNE2999-67-0292999670292026-08-26
10603295553601ATTUNE2999-67-0302999670302026-08-26
10603295553618ATTUNE2999-67-0312999670312026-08-26
10603295552680ATTUNE2999670062999670062026-05-29
10603295555001ATTUNE2999-67-0492999670492026-05-29
10603295555018ATTUNE2999-67-0502999670502026-05-29
10603295555025ATTUNE2999-67-0512999670512026-05-29
10603295555032ATTUNE2999-67-0522999670522026-05-29
10603295555049ATTUNE2999-67-0532999670532026-05-29
10603295555056ATTUNE2999-67-0542999670542026-05-29
10603295555544ATTUNE2999-67-0842999670842026-05-29
10603295555582ATTUNE2999-67-0852999670852026-05-29
10603295015154DURALOC1220-28-1481220281482015-09-24
10603295015161DURALOC1220-28-1501220281502015-09-24
10603295015178DURALOC1220-28-1521220281522015-09-24
10603295015185DURALOC1220-28-1541220281542015-09-24
10603295015192DURALOC1220-28-1561220281562015-09-24
10603295015208DURALOC1220-28-1581220281582015-09-24
10603295015215DURALOC1220-28-1601220281602015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192629032071LineageMicroport Orthopedics Inc.JDI2026-08-18
00192629031937LineageMicroport Orthopedics Inc.JDI2026-08-17
00193982895006TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895167TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895174TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895181TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895198TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895204TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895211TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895228TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895235TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895242TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895266TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895273TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895280TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895297TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14