FDA.reportPublic FDA data

NA

Primary DI
10603295033899
Brand
NA
Company
DEPUY (IRELAND)
Model
1365-50-000
Catalog number
136550000
Device description
M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 36mm -2
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
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980513000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980513000ARTICUL/EZE FEMORAL HEADSDePuy Orthopaedics, Inc.1998-04-14JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295033899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329503389910603295033899

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
10603295518761SMARTSET5450-45-5005450455002026-09-10
10603295168324SMARTSET3092-02030920202015-09-24
10603295168331SMARTSET3092-04030920402015-09-24
10603295168355SMARTSET3102-08031020802015-09-24
10603295168362SMARTSET3122-02031220202015-09-24
10603295168379SMARTSET3122-04031220402015-09-24
10603295168614NA3312-04033120402015-09-24
10603295168621NA3322-02033220202015-09-24
10603295168638NA3332-04033320402015-09-24
10603295174264NA5450-31-5005450315002015-09-24
10603295174271NA5450-32-5005450325002015-09-24
10603295174288SMARTSET5450-35-5005450355002015-09-24
10603295174295SMARTSET5450-50-5015450505012015-09-24
10603295202486SMARTMIX CEMVAC83-16038316032018-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024713512G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713529G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713536G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713543G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713550G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713567G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713574G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713581G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713598G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713604G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713611G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713628G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713635G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713642G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713659G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713666G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713673G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713680G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713697G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713703G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713734G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713741G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713758G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713765G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713772G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713789G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713796G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713802G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713819G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713826G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03