FDA.reportPublic FDA data

CORAIL

Primary DI
10603295455387
Brand
CORAIL
Company
DEPUY (IRELAND)
Model
L971208
Catalog number
L971208
Device description
CORAIL HIP SYSTEM CEMENTLESS FEMORAL STEM HA COATED 12/14 AMT 125 DEGREES STANDARD COLLAR SIZE 8
Published
2019-03-22
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
KWLProsthesis, hip, hemi-, femoral, metal
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173960000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173960000DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.2018-09-21LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295455387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329545538710603295455387

GMDN Terms#

Term, Definition table
TermDefinition
Coated femoral stem prosthesis, modularA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, typically made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

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
10603295168324SMARTSET3092-02030920202015-09-24
10603295168331SMARTSET3092-04030920402015-09-24
10603295168614NA3312-04033120402015-09-24
10603295168621NA3322-02033220202015-09-24
10603295168638NA3332-04033320402015-09-24
10603295005438GLOBAL AP1130-02-0001130020002015-09-24
10603295218289S-ROM87-34358734352015-09-24
10603295218470S-ROM87-35568735562015-09-24
10603295218487S-ROM87-35578735572015-09-24
10603295218951S-ROM87-59878759872015-09-24
10603295519935VELYS4515-70-2264515702262021-05-26
10603295519430VELYS4515-70-1024515701022021-05-13
10603295519492VELYS4515-70-1014515701012021-05-13
10603295519515VELYS4515-70-1004515701002021-05-13
10603295519379VELYS4515-70-1074515701072021-05-07
10603295519461VELYS4515-70-1054515701052021-05-07
10603295519478VELYS4515-70-1064515701062021-05-07
10603295519485VELYS4515-70-1094515701092021-05-07
10603295170655S-ROM52-15035215032015-09-24
10603295170662S-ROM52-15045215042015-09-24

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 LTDKWY2025-04-07
05056139247293Icona Hip StemCORIN LTDLZO2025-04-07
05056139247293Icona Hip StemCORIN LTDKWL2025-04-07
05056139247293Icona Hip StemCORIN LTDMEH2025-04-07
10885862022448NAExactech, Inc.MEH2022-09-19
10885862022448NAExactech, Inc.LZO2022-09-19
10885862022455NAExactech, Inc.LZO2022-09-19
10885862022455NAExactech, Inc.MEH2022-09-19
10885862029867NAExactech, Inc.LZO2022-09-19
10885862034038NovationExactech, Inc.MEH2022-09-19
10885862034038NovationExactech, Inc.LZO2022-09-19
10885862034045NovationExactech, Inc.LZO2022-09-19
10885862034045NovationExactech, Inc.MEH2022-09-19
10885862034052NovationExactech, Inc.LZO2022-09-19
10885862034052NovationExactech, Inc.MEH2022-09-19
10885862034069NovationExactech, Inc.LZO2022-09-19
10885862034069NovationExactech, Inc.MEH2022-09-19
10885862034076NovationExactech, Inc.MEH2022-09-19