FDA.reportPublic FDA data

Vilex Jones Fracture

Primary DI
00841731123077
Brand
Vilex Jones Fracture
Company
VILEX LLC
Model
JF-WASH-60T
Device description
Washer, Jones Fracture 6.0mm Ti
Published
2019-08-16
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
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191289000Bone Screw Line AdditionVilex IN Tennessee, Inc.2019-07-29HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731123077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731123077008417311230778417311230770841731123077

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone washer, non-sterileA non-sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
117502293
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841731147431OPTIXOX2-0011OX2-00112026-03-03
00841731140395ARTEMIS FUZEAV40-20T-16V2026-07-22
00841731140401ARTEMIS FUZEAV40-22T-16V2026-07-22
00841731140418ARTEMIS FUZEAV40-24T-16V2026-07-22
00841731140425ARTEMIS FUZEAV40-26T-16V2026-07-22
00841731140432ARTEMIS FUZEAV40-28T-16V2026-07-22
00841731140449ARTEMIS FUZEAV40-30T-16V2026-07-22
00841731140456ARTEMIS FUZEAV40-32T-16V2026-07-22
00841731140463ARTEMIS FUZEAV40-34T-16V2026-07-22
00841731140470ARTEMIS FUZEAV40-36T-16V2026-07-22
00841731140487ARTEMIS FUZEAV40-38T-16V2026-07-22
00841731140494ARTEMIS FUZEAV40-40T-16V2026-07-22
00841731140500ARTEMIS FUZEAV40-42T-16V2026-07-22
00841731140517ARTEMIS FUZEAV40-44T-16V2026-07-22
00841731140524ARTEMIS FUZEAV40-46T-16V2026-07-22
00841731140531ARTEMIS FUZEAV40-48T-16V2026-07-22
00841731140548ARTEMIS FUZEAV40-50T-16V2026-07-22
00841731140555ARTEMIS FUZEAV40-52T-16V2026-07-22
00841731140562ARTEMIS FUZEAV40-54T-16V2026-07-22
00841731140593ARTEMIS FUZEAV30-16T-11V2026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14053613298657KOMET GUIDE PIN/SCREWGebr. Brasseler GmbH & Co. KGHWC2026-10-14
08057717550535BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550542BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550566BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550580BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550597BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550610BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550627BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550641BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550665BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550689BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550702BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550009BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550016BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550023BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550030BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550047BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550061BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550290BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550313BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550368BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550382BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550405BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550429BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550443BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550467BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550481BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550504BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550528BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550559BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09