FDA.reportPublic FDA data

Unitrax

Primary DI
07613327013368
Brand
Unitrax
Company
Howmedica Osteonics Corp.
Model
6942-6-010
Catalog number
6942-6-010
Device description
Neck Adjustment Sleeve
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
KWLProsthesis, hip, hemi-, femoral, metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K902365000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K902365000MODULAR UNIPOLAR SYSTEMHowmedica Corp.1991-01-11KWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327013368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327013368076133270133687613327013368

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated hip femur prosthesis, one-pieceA sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is one-piece and is not coated with materials intended to improve fixation and stability. 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
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
07613327036503Triathlon5585-C-0165585-C-0162015-09-24
07613327036510Triathlon5585-C-0205585-C-0202015-09-24
07613327036527Triathlon5585-C-0255585-C-0252015-09-24
07613327036534Triathlon5585-C-0305585-C-0302015-09-24
07613327036541Triathlon5585-C-0355585-C-0352015-09-24
07613327036558Triathlon5585-C-0405585-C-0402015-09-24
07613327036565Triathlon5585-C-0455585-C-0452015-09-24
07613327036572Triathlon5585-C-0505585-C-0502015-09-24
07613327036589Triathlon5585-C-0555585-C-0552015-09-24
07613327036596Triathlon5585-C-0605585-C-0602015-09-24
07613327041071Triathlon5520-M-1005520-M-1002015-09-24
07613327041095Triathlon5520-M-2005520-M-2002015-09-24
07613327041101Triathlon5520-M-3005520-M-3002015-09-24
07613327041118Triathlon5520-M-4005520-M-4002015-09-24
07613327041125Triathlon5520-M-5005520-M-5002015-09-24
07613327041132Triathlon5520-M-6005520-M-6002015-09-24
07613327041149Triathlon5520-M-7005520-M-7002015-09-24
07613327041156Triathlon5520-M-8005520-M-8002015-09-24
07613327041392Triathlon5527-B-1005527-B-1002015-09-24
07613327041408Triathlon5527-B-3005527-B-3002015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011453476REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWL2026-06-01
00850011453483REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWL2026-06-01
00850011453490REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWL2026-06-01
00850011453506REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWL2026-06-01
00850011453513REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWL2026-06-01
00850011453520REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWL2026-06-01
07613153071273RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071280RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071310RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071327RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071334RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071358RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071365RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071372RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071389RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071396RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071419RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071433RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071440RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071518RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071587RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071600RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071617RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071631RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071648RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071655RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153072867TridentHowmedica Osteonics Corp.KWL2015-09-24
07613153072874TridentHowmedica Osteonics Corp.KWL2015-09-24
07613153072898TridentHowmedica Osteonics Corp.KWL2015-09-24
07613153072904TridentHowmedica Osteonics Corp.KWL2015-09-24