FDA.reportPublic FDA data

PINNACLE

Primary DI
10603295012269
Brand
PINNACLE
Company
DEPUY ORTHOPAEDICS, INC.
Model
1218-44-670
Catalog number
121844670
Device description
PINNACLE HIP SOLUTIONS GVF POLYETHYLENE CONSTRAINED ACETABULAR LINER +4 NEUTRAL 44mm ID 70mm OD
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295012269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329501226910603295012269

GMDN Terms#

Term, Definition table
TermDefinition
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 may include a stabilizing component (e.g., a ring) to limit the range of motion of the hip to help prevent dislocation.

Sterilization Methods#

Method table
Method

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
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
10603295015222DURALOC1220-28-1621220281622015-09-24
10603295015239DURALOC1220-28-1641220281642015-09-24
10603295015246DURALOC1220-28-1661220281662015-09-24
10603295015536DURALOC1220-32-1521220321522015-09-24
10603295015543DURALOC1220-32-1541220321542015-09-24
10603295015550DURALOC1220-32-1561220321562015-09-24
10603295015567DURALOC1220-32-1581220321582015-09-24
10603295015574DURALOC1220-32-1601220321602015-09-24
10603295015581DURALOC1220-32-1621220321622015-09-24
10603295015598DURALOC1220-32-1641220321642015-09-24
10603295015604DURALOC1220-32-1661220321662015-09-24
10603295155010NA2841-10-0002841100002018-09-24
10603295552390ATTUNE2999-66-9712999669712026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613153071273RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071297RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071310RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071327RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071334RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071341RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071365RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071372RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071389RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071396RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071402RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071419RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071426RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071433RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071440RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071587RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071594RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071600RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071617RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071648RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071655RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153072867TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072874TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072881TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072898TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072904TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072911TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072928TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072935TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072942TridentHowmedica Osteonics Corp.KWZ2015-09-24