FDA.reportPublic FDA data

ELITE PLUS

Primary DI
10603295318521
Brand
ELITE PLUS
Company
DEPUY (IRELAND)
Model
9651-28-040
Catalog number
965128040
Device description
ELITE PLUS Cup - CEMENTED LPW 28mmID 40mmOD
Published
2015-09-24
Public version status
Update
Distribution status
Not 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
K871867000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K871867000ELITE MODULAR HIP SYSTEMThackray USA1988-04-08JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295318521PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329531852110603295318521

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular shellAn implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
989365556
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295033141S-ROM1365-16-5001365165002015-09-24
10603295033158S-ROM1365-17-5001365175002015-09-24
10603295033165S-ROM1365-18-5001365185002015-09-24
10603295033738S-ROM1365-41-5001365415002015-09-24
10603295033752S-ROM1365-42-5001365425002015-09-24
10603295033776S-ROM1365-43-5001365435002015-09-24
10603295033790S-ROM1365-44-5001365445002015-09-24
10603295033851S-ROM1365-45-5001365455002015-09-24
10603295033875S-ROM1365-47-5001365475002015-09-24
10603295034056S-ROM1365-61-5001365615002015-09-24
10603295034094S-ROM1365-62-5001365625002015-09-24
10603295034131S-ROM1365-63-5001365635002015-09-24
10603295034179S-ROM1365-64-5001365645002015-09-24
10603295034216S-ROM1365-65-5001365655002015-09-24
10603295034230S-ROM1365-66-5001365665002015-09-24
10603295170778S-ROM52-20225220222015-09-24
10603295079941AML EXCEL2001-42-0002001420002018-09-24
10603295080008AML EXCEL2001-47-0002001470002018-09-24
10603295080015AML EXCEL2001-48-0002001480002018-09-24
10603295080022AML EXCEL2001-49-0002001490002018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810068850079Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850086Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850093Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850109Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850123Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850130Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850147Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850154Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850185Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850192Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850208Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850215Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850222Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850239Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850246Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850284Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850307Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850321Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850338Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850345Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850635Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850642Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850703Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850710Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850727Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850734Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850741Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850758Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850772Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850895Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26