FDA.reportPublic FDA data

TITANEX

Primary DI
00841731137951
Brand
TITANEX
Company
VILEX LLC
Model
TH-DT7
Device description
TITANEX MICROBEAM DRIVER, T7 STRAIGHT
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
LRZScrewdriver, surgical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231504000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231504000TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw SystemVilex, LLC2023-09-11HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731137951PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731137951008417311379518417311379510841731137951

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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
B8034500040ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034709510ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034709530ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034709540ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034709560ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034709580ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034709610ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803480ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803490ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803500ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803520ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803530ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803540ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803550ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803560ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803580ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803600ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803620ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
00196449017348A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00196449017379A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00196449017386A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00196449017393A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00196449017454A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00196449017553A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
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