FDA.report

PINNACLE

Primary DI
10603295014591
Brand
PINNACLE
Company
DEPUY ORTHOPAEDICS, INC.
Model
1219-36-156
Catalog number
121936156
Device description
PINNACLE HIP SOLUTIONS MARATHON POLYETHYLENE ACETABULAR LINER +4 10 DEGREE 36mm ID 56mm OD
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Product Code Classifications

CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10603295014591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1060329501459110603295014591

GMDN Terms

TermDefinition
Non-constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags

DUNS number
080506581
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10603295553625ATTUNE2999-67-0322999670322026-02-17
10603295553632ATTUNE2999-67-0332999670332026-02-17
10603295553649ATTUNE2999-67-0342999670342026-02-17
10603295553656ATTUNE2999-67-0352999670352026-02-17
10603295554974EMPHASYS2999-67-0462999670462026-02-04
10603295080121AML EXCEL2001-65-0002001650002018-06-15
10603295082408DURALOC2015-24-0002015240002018-09-24
10603295083382SIGMA2024-57-1112024571112018-09-24
10603295084075SIGMA2024-85-0052024850052018-09-24
10603295088042GLOBAL FX2128-01-0222128010222018-09-24
10603295090540GLOBAL AP2130-01-0552130010552018-09-24
10603295090687GLOBAL AP2130-04-0002130040002018-09-24
10603295094005NA2178-30-1222178301222018-09-24
10603295095651LCS COMPLETION2178-60-0282178600282018-09-24
10603295096184NA2178-63-1242178631242018-09-24
10603295096191NA2178-63-1262178631262018-09-24
10603295098935PINNACLE2217-50-0042217500042018-09-24
10603295098942PINNACLE2217-50-0052217500052018-09-24
10603295098959PINNACLE2217-50-0062217500062018-09-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10885862660633N/AExactech, Inc.LPH2026-03-19
04580810066831Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810066909Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
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04580810067821Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810067845Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810067869Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068163Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068170Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068187Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068194Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
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04580810068422Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
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04580810068668Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068699Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068705Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068712Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068729Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068736Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068743Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068750Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068767Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068774Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068781Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068798Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068804Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068811Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068828Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27