FDA.reportPublic FDA data

TITANEX

Primary DI
00841731138125
Brand
TITANEX
Company
VILEX LLC
Model
ART-STP-49
Device description
ARTEMIS ZADEX SOFT TISSUE PROTECTOR
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
K250304000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250304000TITANEX Screw SystemsVilex, LLC2025-03-05HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731138125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731138125008417311381258417311381250841731138125

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
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
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
00841731141934TITANEX AZ-DPTH2026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840286860093Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860109Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860116Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
10705034647463N/AMedos International SàrlLXH2026-07-09
B382SD49400B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49401B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49402B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49403B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49404B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49405B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49406B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49407B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49408B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49409B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49410B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49411B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49412B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49413B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49414B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49415B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49416B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49417B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49418B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49419B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49420B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500010Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500020Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500030Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500040Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500050Surgical DirectSurgical Direct, Inc.LXH2026-07-09