FDA.reportPublic FDA data

Omnifit

Primary DI
04546540003621
Brand
Omnifit
Company
Howmedica Osteonics Corp.
Model
J6098-0630
Catalog number
J6098-0630
Device description
132 Degree Cemented Hip Stem
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

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
K020989000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020989000SUPER EON PLUS FEMORAL STEMSHowmedica Osteonics Corp.2002-04-26JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540003621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540003621045465400036214546540003621

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].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058311945
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327027730Triathlon5610-F-1015610-F-1012015-09-24
07613327027747Triathlon5610-F-2015610-F-2012015-09-24
07613327027754Triathlon5610-F-1025610-F-1022015-09-24
07613327027761Triathlon5610-F-2025610-F-2022015-09-24
07613327027778Triathlon5610-F-3015610-F-3012015-09-24
07613327027785Triathlon5610-F-3025610-F-3022015-09-24
07613327027792Triathlon5610-F-4015610-F-4012015-09-24
07613327027808Triathlon5610-F-4025610-F-4022015-09-24
07613327027815Triathlon5610-F-5025610-F-5022015-09-24
07613327027822Triathlon5610-F-6015610-F-6012015-09-24
07613327027839Triathlon5610-F-6025610-F-6022015-09-24
07613327027846Triathlon5610-F-5015610-F-5012015-09-24
07613327207163INSTRUMENT5510-T-1015510-T-1012016-09-24
07613327208832INSTRUMENT1100-12251100-12252016-09-24
07613327012804V40 Head6260-4-2226260-4-2222015-09-24
07613327012811V40 Head6260-4-3226260-4-3222015-09-24
07613327012828V40 Head6260-5-0266260-5-0262015-09-24
07613327012835V40 Head6260-5-0286260-5-0282015-09-24
07613327012842V40 Head6260-5-0326260-5-0322015-09-24
07613327012859V40 Head6260-5-1266260-5-1262015-09-24

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