FDA.reportPublic FDA data

SUMMIT

Primary DI
10603295060604
Brand
SUMMIT
Company
DEPUY ORTHOPAEDICS, INC.
Model
1570-24-015
Catalog number
157024015
Device description
SUMMIT FEMORAL STEM 12/14 TAPER CEMENTED SIZE 5 HI 120mm
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
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013352000
K023453000
K030122000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013352000SUMMIT CEMENTED HIP PROSTHESISDePuy Orthopaedics, Inc.2001-12-17JDI
K023453000DEPUY SUMMIT FX CEMENTED HIP PROSTHESISDePuy Orthopaedics, Inc.2002-11-13JDI
K030122000DEPUY SUMMIT BASIC PRESS-FIT HIP STEMDePuy Orthopaedics, Inc.2003-02-05LWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295060604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329506060410603295060604

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
10885862015181AuraExactech, Inc.JDI2022-10-04
10885862015198AuraExactech, Inc.JDI2022-10-04
10885862015204AuraExactech, Inc.JDI2022-10-04
10885862015211AuraExactech, Inc.JDI2022-10-04
10885862013743NAExactech, Inc.JDI2022-09-20
10885862013750NAExactech, Inc.JDI2022-09-20
10885862022448NAExactech, Inc.JDI2022-09-19
10885862022455NAExactech, Inc.JDI2022-09-19
10885862029867NAExactech, Inc.JDI2022-09-19
10885862029867NAExactech, Inc.LWJ2022-09-19
10885862034038NovationExactech, Inc.JDI2022-09-19
10885862034038NovationExactech, Inc.LWJ2022-09-19
10885862034045NovationExactech, Inc.LWJ2022-09-19
10885862034045NovationExactech, Inc.JDI2022-09-19
10885862034052NovationExactech, Inc.LWJ2022-09-19
10885862034052NovationExactech, Inc.JDI2022-09-19
10885862034069NovationExactech, Inc.JDI2022-09-19
10885862034069NovationExactech, Inc.LWJ2022-09-19
10885862034076NovationExactech, Inc.LWJ2022-09-19
10885862034076NovationExactech, Inc.JDI2022-09-19
10885862034083NovationExactech, Inc.LWJ2022-09-19
10885862034083NovationExactech, Inc.JDI2022-09-19
10885862034090NovationExactech, Inc.LWJ2022-09-19
10885862034090NovationExactech, Inc.JDI2022-09-19
10885862034106NovationExactech, Inc.LWJ2022-09-19
10885862034106NovationExactech, Inc.JDI2022-09-19
10885862034113NovationExactech, Inc.JDI2022-09-19
10885862034113NovationExactech, Inc.LWJ2022-09-19
10885862033598NovationExactech, Inc.JDI2022-08-25
10885862033598NovationExactech, Inc.LWJ2022-08-25