FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00888912079532
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
426-10-050
Device description
HIP, STEM, CLP, STANDARD, SIZE#5, IMPLANT, POLISHED NECK
Published
2017-08-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K932481000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K932481000SL-PLUS AND SLR-PLUSEncore Orthopedics, Inc.1994-06-08JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888912079532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888912079532008889120795328889120795320888912079532

GMDN Terms#

Term, Definition table
TermDefinition
Press-fit femoral stem prosthesisA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154074504
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888912024983DJO SURGICAL520-38-0142017-08-07
00888912024990DJO SURGICAL520-38-0182017-08-07
00888912025003DJO SURGICAL520-38-1182017-08-07
00888912025010DJO SURGICAL520-42-0202017-08-07
00888912025027DJO SURGICAL520-42-1162017-08-07
00888912025034DJO SURGICAL520-46-1162017-08-07
00888912025041DJO SURGICAL520-46-1202017-08-07
00888912025058DJO SURGICAL520-50-1182017-08-07
00888912025065DJO SURGICAL520-50-1222017-08-07
00888912025072DJO SURGICAL520-50-1262017-08-07
00888912025089DJO SURGICAL520-54-1182017-08-07
00888912145114DJO SURGICAL520-42-0162017-08-07
00888912145138DJO SURGICAL520-42-1202017-08-07
00888912145145DJO SURGICAL520-46-0162017-08-07
00888912145152DJO SURGICAL520-46-0202017-08-07
00888912145169DJO SURGICAL520-46-0242017-08-07
00888912145190DJO SURGICAL520-46-1242017-08-07
00888912145206DJO SURGICAL520-50-0182017-08-07
00888912145213DJO SURGICAL520-50-0222017-08-07
00888912145220DJO SURGICAL520-50-0262017-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024707160G7® Vivacit-E®Zimmer, Inc.JDI2026-09-30
00889024707177G7® Acetabular SystemBiomet Orthopedics, LLCJDI2026-09-30
00889024707184G7® Vivacit-E®Zimmer, Inc.JDI2026-09-30
00889024707191G7® Acetabular SystemBiomet Orthopedics, LLCJDI2026-09-30
00889024707207G7® Vivacit-E®Zimmer, Inc.JDI2026-09-30
00889024707214G7® Acetabular SystemBiomet Orthopedics, LLCJDI2026-09-30
E31442100200SignatureMaterialise NVJDI2026-09-24
E31442100300SignatureMaterialise NVJDI2026-09-24
10885862015181AuraExactech, Inc.JDI2022-10-04
10885862015198AuraExactech, Inc.JDI2022-10-04
10885862015204AuraExactech, Inc.JDI2022-10-04
10885862015211AuraExactech, Inc.JDI2022-10-04
10885862013743NAExactech, Inc.JDI2022-09-20
10885862013750NAExactech, Inc.JDI2022-09-20
10885862022448NAExactech, Inc.JDI2022-09-19
10885862022455NAExactech, Inc.JDI2022-09-19
10885862029867NAExactech, Inc.JDI2022-09-19
10885862034038NovationExactech, Inc.JDI2022-09-19
10885862034045NovationExactech, Inc.JDI2022-09-19
10885862034052NovationExactech, Inc.JDI2022-09-19
10885862034069NovationExactech, Inc.JDI2022-09-19
10885862034076NovationExactech, Inc.JDI2022-09-19
10885862034083NovationExactech, Inc.JDI2022-09-19
10885862034090NovationExactech, Inc.JDI2022-09-19
10885862034106NovationExactech, Inc.JDI2022-09-19
10885862034113NovationExactech, Inc.JDI2022-09-19
10885862033598NovationExactech, Inc.JDI2022-08-25
10885862033604NovationExactech, Inc.JDI2022-08-25
10885862033611NovationExactech, Inc.JDI2022-08-25
10885862033628NovationExactech, Inc.JDI2022-08-25