FDA.reportPublic FDA data

PINNACLE GRIPTION TF

Primary DI
10603295008415
Brand
PINNACLE GRIPTION TF
Company
DEPUY (IRELAND)
Model
1217-00-105
Catalog number
121700105
Device description
PINNACLE GRIPTION TF HIP SHIM 5 DEGREE
Published
2015-09-24
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
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100391000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100391000DEPUY UNIVERSAL GRIPTION TF CONESDePuy Orthopaedics, Inc.2010-09-29JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295008415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329500841510603295008415

GMDN Terms#

Term, Definition table
TermDefinition
Metallic acetabulum prosthesisA sterile implantable principal component of a total hip prosthesis (acetabular component) designed to replace or repair the acetabulum. The component is of a one-piece construction and is made entirely of metal [e.g., stainless steel, titanium (Ti)]. Devices designed to assist implantation/fixation (e.g., screws, surgical guides, trial prosthesis, anatomical models) may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
989365556
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295541325ATTUNE1518-20-1051518201052021-08-27
10603295541332ATTUNE1518-20-1061518201062021-08-27
10603295541349ATTUNE1518-20-1071518201072021-08-27
10603295541356ATTUNE1518-20-1081518201082021-08-27
10603295541363ATTUNE1518-20-1101518201102021-08-27
10603295541370ATTUNE1518-20-1121518201122021-08-27
10603295541387ATTUNE1518-20-1141518201142021-08-27
10603295541394ATTUNE1518-20-1161518201162021-08-27
10603295541400ATTUNE1518-20-2051518202052021-08-27
10603295541417ATTUNE1518-20-2061518202062021-08-27
10603295541424ATTUNE1518-20-2071518202072021-08-27
10603295541431ATTUNE1518-20-2081518202082021-08-27
10603295541448ATTUNE1518-20-2101518202102021-08-27
10603295541455ATTUNE1518-20-2121518202122021-08-27
10603295541462ATTUNE1518-20-2141518202142021-08-27
10603295541479ATTUNE1518-20-2161518202162021-08-27
10603295541486ATTUNE1518-20-3051518203052021-08-27
10603295541493ATTUNE1518-20-3061518203062021-08-27
10603295541509ATTUNE1518-20-3071518203072021-08-27
10603295541516ATTUNE1518-20-3081518203082021-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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05056139247989Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248047Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248054Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248061Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248078Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248085Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248146Unity Total Knee SystemCORIN LTDJWH2026-10-23
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05056139248160Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248177Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248184Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248597Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249013Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249020Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249037Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249044Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249303Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249310Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249327Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249334Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249341Unity Total Knee SystemCORIN LTDJWH2026-10-23