FDA.reportPublic FDA data

RECLAIM

Primary DI
10603295077152
Brand
RECLAIM
Company
DEPUY (IRELAND)
Model
1977-14-190
Catalog number
197714190
Device description
RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 14mm X 190mm ANGLED
Published
2015-03-24
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
KWAProsthesis, hip, semi-constrained (metal uncemented acetabular component)
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)Orthopedic3
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102080000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102080000DEPUY RECLAIM REVISION HIP SYSTEMDepuy(Ireland)2010-11-23LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295077152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329507715210603295077152

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) typically designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with 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
05056139247293Icona Hip StemCORIN LTDLZO2025-04-07
10885862022448NAExactech, Inc.LZO2022-09-19
10885862022455NAExactech, Inc.LZO2022-09-19
10885862029867NAExactech, Inc.LZO2022-09-19
10885862034038NovationExactech, Inc.LZO2022-09-19
10885862034045NovationExactech, Inc.LZO2022-09-19
10885862034052NovationExactech, Inc.LZO2022-09-19
10885862034069NovationExactech, Inc.LZO2022-09-19
10885862034076NovationExactech, Inc.LZO2022-09-19
10885862034083NovationExactech, Inc.LZO2022-09-19
10885862034090NovationExactech, Inc.LZO2022-09-19
10885862034106NovationExactech, Inc.LZO2022-09-19
10885862034113NovationExactech, Inc.LZO2022-09-19
10885862033598NovationExactech, Inc.LZO2022-08-25
10885862033604NovationExactech, Inc.LZO2022-08-25
10885862033611NovationExactech, Inc.LZO2022-08-25
10885862033628NovationExactech, Inc.LZO2022-08-25
10885862033635NovationExactech, Inc.LZO2022-08-25
10885862033642NovationExactech, Inc.LZO2022-08-25
10885862033741NovationExactech, Inc.LZO2022-08-25
10885862033758NovationExactech, Inc.LZO2022-08-25
10885862033765NovationExactech, Inc.LZO2022-08-25
10885862010872NAExactech, Inc.LZO2022-08-18
10885862010889NAExactech, Inc.LZO2022-08-18
10885862010896NAExactech, Inc.LZO2022-08-18
10885862016690NAExactech, Inc.LZO2022-08-18
10885862016706NAExactech, Inc.LZO2022-08-18
10885862016713NAExactech, Inc.LZO2022-08-18
10885862016720NAExactech, Inc.LZO2022-08-18
10885862016737NAExactech, Inc.LZO2022-08-18