FDA.reportPublic FDA data

DYNEX

Primary DI
00841731152152
Brand
DYNEX
Company
VILEX LLC
Model
DXT-TTT-10
Device description
DYNEX TRIAD dia 4.5mm Drill Guide
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260900000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260900000DYNEX® External Fixation SystemsVilex, LLC2026-04-17KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731152152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731152152008417311521528417311521520841731152152

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00N/A

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)521-5002info@vilex.com

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
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
00841731140609ARTEMIS FUZEAV30-18T-11V2026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00721902746383MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-08-15
00763000654771Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-08-15
00763000654788Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-08-15
00763000654795Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-08-15
00193982003630N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982016340N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145491N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145507N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145514N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145538N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145545N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145552N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145569N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145576N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145583N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145590N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145606N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145613N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145620N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145637N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145644N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145651N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145668N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145675N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145682N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145699N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145705N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145712N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145729N/AGLOBUS MEDICAL, INC.LXH2026-08-14
00193982145736N/AGLOBUS MEDICAL, INC.LXH2026-08-14