FDA.reportPublic FDA data

PINNACLE

Primary DI
10603295523949
Brand
PINNACLE
Company
DEPUY ORTHOPAEDICS, INC.
Model
1217-98-486
Catalog number
121798486
Device description
PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF012420.013) FOR CEMENTLESS USE ONLY 56MM LEFT
Published
2020-06-24
Public version status
Update
Distribution status
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
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040383000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040383000TRIFLANGE II ACETABULAR CUP SYSTEMDePuy Orthopaedics, Inc.2004-05-12LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295523949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329552394910603295523949

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular shellA sterile, 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
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
10603295553588ATTUNE2999-67-0282999670282026-08-26
10603295553595ATTUNE2999-67-0292999670292026-08-26
10603295553601ATTUNE2999-67-0302999670302026-08-26
10603295553618ATTUNE2999-67-0312999670312026-08-26
10603295552680ATTUNE2999670062999670062026-05-29
10603295555001ATTUNE2999-67-0492999670492026-05-29
10603295555018ATTUNE2999-67-0502999670502026-05-29
10603295555025ATTUNE2999-67-0512999670512026-05-29
10603295555032ATTUNE2999-67-0522999670522026-05-29
10603295555049ATTUNE2999-67-0532999670532026-05-29
10603295555056ATTUNE2999-67-0542999670542026-05-29
10603295555544ATTUNE2999-67-0842999670842026-05-29
10603295555582ATTUNE2999-67-0852999670852026-05-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630542796555Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796562Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796579Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796586Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796593Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796609Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796616Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796623Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796630Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796647Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796654Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796661Mfinity Femoral SystemMedacta International SAMEH2026-08-25
05056139247293Icona Hip StemCORIN LTDMEH2025-04-07
10885862013743NAExactech, Inc.LPH2022-09-20
10885862013750NAExactech, Inc.LPH2022-09-20
10885862022448NAExactech, Inc.LPH2022-09-19
10885862022448NAExactech, Inc.MEH2022-09-19
10885862022455NAExactech, Inc.MEH2022-09-19
10885862022455NAExactech, Inc.LPH2022-09-19
10885862029867NAExactech, Inc.LPH2022-09-19
10885862034038NovationExactech, Inc.MEH2022-09-19
10885862034045NovationExactech, Inc.MEH2022-09-19
10885862034052NovationExactech, Inc.MEH2022-09-19
10885862034069NovationExactech, Inc.MEH2022-09-19
10885862034076NovationExactech, Inc.MEH2022-09-19
10885862034083NovationExactech, Inc.MEH2022-09-19
10885862034090NovationExactech, Inc.MEH2022-09-19
10885862034106NovationExactech, Inc.MEH2022-09-19
10885862034113NovationExactech, Inc.MEH2022-09-19
10885862033598NovationExactech, Inc.MEH2022-08-25