FDA.reportPublic FDA data

DYNEX

Primary DI
00841731152237
Brand
DYNEX
Company
VILEX LLC
Model
DXT-TTT-18
Device description
DYNEX TRIAD Adjustment Tool
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRZScrewdriver, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRZScrewdriver, SurgicalGeneral, Plastic Surgery1

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
00841731152237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731152237008417311522378417311522370841731152237

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system noninvasive component, single-useA noninvasive structural component of an external orthopaedic fixation system intended for bone/joint fracture stabilization in conjunction with an invasive bone pin (not included). It is in the form of a full or partial ring, rod (e.g., straight, curved, telescopic), plate, or connector (e.g., screw, bolt, nut, hinge, coupling, fastener); it is not a surgical instrument. This is a single-use 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
00841731135483TITANEX H4102026-05-15
00841731135568TITANEX K150-16SC2026-05-15
00841731137319TITANEX ART-KW2-1012026-05-15
00841731137906TITANEXK150-09S2026-05-15
00841731137913TITANEX TH-DRILL-202026-05-15
00841731137920TITANEX TH-DRILL-252026-05-15
00841731137937TITANEXTH-DEPTHTH-DEPTH2026-05-15
00841731137951TITANEX TH-DT72026-05-15
00841731137968TITANEX TH-DT82026-05-15
00841731138095TITANEX ART-KW2-1902026-05-15
00841731138101TITANEX ART-KWS-222026-05-15
00841731138118TITANEX ART-DTH-652026-05-15
00841731138125TITANEX ART-STP-492026-05-15
00841731138132TITANEX ART-DBC-492026-05-15
00841731138149TITANEX ART-RT-T252026-05-15
00841731138156TITANEX ART-VZO-152026-05-15
00841731140777TITANEX AZ-D130-262026-05-15
00841731140784TITANEX AZ-DT10-CR2026-05-15
00841731141910TITANEX AZ-D150-332026-05-15
00841731141927TITANEX AZ-DT15-CR2026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731137951TITANEX VILEX LLCLRZ2026-05-15
00841731137968TITANEX VILEX LLCLRZ2026-05-15
00841731138149TITANEX VILEX LLCLRZ2026-05-15
00841731140784TITANEX VILEX LLCLRZ2026-05-15
00841731141927TITANEX VILEX LLCLRZ2026-05-15
00841731146816TITANEX VILEX LLCLRZ2026-05-15
00841731146823TITANEX VILEX LLCLRZ2026-05-15
00841731146830TITANEX VILEX LLCLRZ2026-05-15
00841731146847TITANEX VILEX LLCLRZ2026-05-15
00841731152121DYNEX VILEX LLCLRZ2026-05-11
00841731152183DYNEX VILEX LLCLRZ2026-05-11
00841731152282DYNEX VILEX LLCLRZ2026-05-11
08800016101362Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114447Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114454Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114461Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114478Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114485Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016115024Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016115840Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016115857Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016116014Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016144772Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016163087Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016163094Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176742Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176759Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176766Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176773Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176780Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28