FDA.reportPublic FDA data

eZ-Fix

Primary DI
00841731110282
Brand
eZ-Fix
Company
VILEX IN TENNESSEE, INC.
Model
315-320-180T
Device description
FootPlate, Full 180mm Square-End Silver w/Tabs
Published
2016-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052196000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052196000VILEX X-FIXVilex, Inc.2005-11-22KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731110282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731110282008417311102828417311102820841731110282

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, single-use, non-sterileAn assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
152008371
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841731120274Vilex GuidewireK100-09DK100-09D2018-08-06
00841731120281Vilex GuidewireK100-09GK100-09G2018-08-06
00841731120298Vilex GuidewireK100-09SK100-09S2018-08-06
00841731120304Vilex GuidewireK100-11DK100-11D2018-08-06
00841731120311Vilex GuidewireK100-11PTK100-11PT2018-08-06
00841731120328Vilex GuidewireK100-11SK100-11S2018-08-06
00841731120335Vilex GuidewireK100-12SK100-12S2018-08-06
00841731120342Vilex GuidewireK100-14SK100-14S2018-08-06
00841731120359Vilex GuidewireK100-16DK100-16D2018-08-06
00841731120366Vilex GuidewireK100-16SK100-16S2018-08-06
00841731120373Vilex GuidewireK100-20SK100-20S2018-08-06
00841731120441Vilex Plate GuidewireK11-60TK11-60T2018-08-08
00841731120465Vilex GuidewireK150-09DK150-09D2018-08-08
00841731120472Vilex GuidewireK150-11DK150-11D2018-08-08
00841731120489Vilex GuidewireK150-11PTK150-11PT2018-08-08
00841731120496Vilex GuidewireK150-11SK150-11S2018-08-08
00841731120502Vilex GuidewireK150-12DK150-12D2018-08-08
00841731120519Vilex GuidewireK150-12SK150-12S2018-08-08
00841731120526Vilex GuidewireK150-14DK150-14D2018-08-08
00841731120533Vilex GuidewireK150-14SK150-14S2018-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903993241486130° Wise-Lock DHS Plate, 2 Holes, Stainless SteelAuxein Medical Private LimitedKTT2026-04-18
08903993241493130° Wise-Lock DHS Plate, 3 Holes, Stainless SteelAuxein Medical Private LimitedKTT2026-04-18
08032909626380ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-17
08051739535730ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-10
08059386747391DOLPHIXCITIEFFE SRLKTT2025-04-02
10080196692729MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692866MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692910MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692927MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692941MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692965MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002065MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
08032909624263ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624270ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624317ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909624355ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909624362ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909627639DOLPHIXCITIEFFE SRLKTT2020-01-10
08052990974535DOLPHIXCITIEFFE SRLKTT2020-01-10
08051739536225ST.A.R. 90 F4CITIEFFE SRLKTT2019-11-29
08051739531244DOLPHIXCITIEFFE SRLKTT2019-05-18
08052990972661DOLPHIXCITIEFFE SRLKTT2019-05-18
08052990974542DOLPHIXCITIEFFE SRLKTT2019-05-18
08052990974566DOLPHIXCITIEFFE SRLKTT2019-05-18
08051739531725DOLPHIXCITIEFFE SRLKTT2019-01-09
08051739531732DOLPHIXCITIEFFE SRLKTT2019-01-09
08051739531749DOLPHIXCITIEFFE SRLKTT2019-01-09
08051739531756DOLPHIXCITIEFFE SRLKTT2018-12-15
08051739531763DOLPHIXCITIEFFE SRLKTT2018-12-15
08051739531770DOLPHIXCITIEFFE SRLKTT2018-12-15