FDA.reportPublic FDA data

ELITE

Primary DI
10603295318064
Brand
ELITE
Company
DEPUY INTERNATIONAL LTD
Model
9625-17-000
Catalog number
962517000
Device description
ELITE CUP OGEE - CEMENTED LPW 32mmID 47mmOD
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
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
JDBPROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
KWIPROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
LZNCEMENT OBTURATOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2
JDBProsthesis, Elbow, Semi-Constrained, CementedOrthopedic2
KWIProsthesis, Elbow, Hemi-, Radial, PolymerOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
LZNCement ObturatorGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K940743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940743000UHMWPE COMPONENTS-CHANGE IN PACKAGINGDepuy, Inc.1995-09-18KWY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295318064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329531806410603295318064

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
896498813
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295155492SIGMA2960-08-4002960084002018-09-24
10603295155508SIGMA2960-09-4002960094002018-09-24
10603295210320NA8555-06-0008555060002018-09-24
10603295119708AML234-52-10002345210002018-09-24
10603295224341NA9505-01-0329505010322018-09-24
10603295224792LCS9505-01-1199505011192018-09-24
10603295226581PATHWAY9505-01-5229505015222018-09-24
10603295226598NA9505-01-5239505015232018-09-24
10603295226604NA9505-01-5249505015242018-09-24
10603295241065CHARNLEY9620-73-0009620730002018-09-24
10603295026853NA1299-01-0291299010292016-06-30
10603295026952NA1299-01-0581299010582018-09-24
10603295147657C-STEM2580-00-0342580000342018-09-24
10603295147664C-STEM2580-00-0352580000352018-09-24
10603295147671C-STEM2580-00-0362580000362018-09-24
10603295147688C-STEM2580-00-0372580000372018-09-24
10603295147695C-STEM2580-00-0382580000382018-09-24
10603295147701C-STEM2580000392580000392018-09-24
10603295147718C-STEM2580000402580000402018-09-24
10603295147725C-STEM2580000412580000412018-09-24

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Primary DI, Brand, Company table
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