FDA.report

PINNACLE ALTRX

Primary DI
10603295016236
Brand
PINNACLE ALTRX
Company
DEPUY ORTHOPAEDICS, INC.
Model
1221-32-260
Catalog number
122132260
Device description
PINNACLE HIP SOLUTIONS ALTRX POLYETHYLENE ACETABULAR LINER LIPPED 32mm ID 60mm 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
10603295016236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1060329501623610603295016236

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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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
04580810067784Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810067807Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
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
04580810068385Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068422Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068620Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
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