FDA.reportPublic FDA data

DURALOC

Primary DI
10603295019404
Brand
DURALOC
Company
DEPUY ORTHOPAEDICS, INC.
Model
1245-38-503
Catalog number
124538503
Device description
DURALOC ACETABULAR CUP SYSTEM BANTAM ACETABULAR SHELL 38mm OD
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
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
JDBPROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2
JDBProsthesis, Elbow, Semi-Constrained, CementedOrthopedic2
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K900832000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K900832000MODIFIED DEPUY ACETABULAR CUP SYSTEM* HIP ACETA.Depuy, Inc.1990-05-04JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295019404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329501940410603295019404

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
10603295555643INHANCE2999-67-0892999670892026-11-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800017265438EXULT Tibial InsertCorentec Co., LtdJWH2026-11-05
08800017265445EXULT Tibial InsertCorentec Co., LtdJWH2026-11-05
00192629475007EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475007EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475014EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475014EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475021EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475021EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475038EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475038EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475045EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475045EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475052EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475052EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475069EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475069EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475076EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475076EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475083EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475083EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475090EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475090EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475106EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475106EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475113EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475113EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475120EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475120EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475137EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475137EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03