TITANEX
- Primary DI
- 00841731137876
- Company
- VILEX LLC
- Model
- TH25-46T-11
- Device description
- TITANEX MICROBEAM 2.5 X 46MM
- Published
- 2026-02-09
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Regulatory Flags
- DUNS number
- 117502293
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00841731137876 | Primary | GS1 | 0 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|---|---|---|---|---|---|---|
| 00841731137876 | Primary | GS1 | 0 |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|---|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | 2 | Orthopedic | 888.3040 | Y | Eligible |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K231504 | 000 |
Premarket Details
GMDN Terms
| Term | Definition |
|---|---|
| Orthopaedic bone screw (non-sliding) | A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver. |
Device Sizes
| Type | Value | Text |
|---|---|---|
| Device Size Text, specify | 0 | NA |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | NA |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | |
|---|---|
| +1(800)521-5002 | info@vilex.com |
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00841731135490 | TITANEX | ART-HD65-40 | ART-HD65-40 | 2026-03-03 |
| 00841731147431 | OPTIX | OX2-0011 | OX2-0011 | 2026-03-03 |
| 00841731149077 | DYNEX MICRO | MR-900-PE-04 | MR-900-PE-04 | 2026-03-03 |
| 00841731137548 | TITANEX | TH20-16T-09 | 2026-02-09 | |
| 00841731137555 | TITANEX | TH20-18T-09 | 2026-02-09 | |
| 00841731137562 | TITANEX | TH20-20T-09 | 2026-02-09 | |
| 00841731137579 | TITANEX | TH20-22T-09 | 2026-02-09 | |
| 00841731137586 | TITANEX | TH20-24T-09 | 2026-02-09 | |
| 00841731137593 | TITANEX | TH20-26T-09 | 2026-02-09 | |
| 00841731137609 | TITANEX | TH20-28T-09 | 2026-02-09 | |
| 00841731137616 | TITANEX | TH20-30T-09 | 2026-02-09 | |
| 00841731137623 | TITANEX | TH20-32T-09 | 2026-02-09 | |
| 00841731137630 | TITANEX | TH20-34T-09 | 2026-02-09 | |
| 00841731137647 | TITANEX | TH20-36T-09 | 2026-02-09 | |
| 00841731137654 | TITANEX | TH20-38T-09 | 2026-02-09 | |
| 00841731137661 | TITANEX | TH20-40T-09 | 2026-02-09 | |
| 00841731137678 | TITANEX | TH20-42T-09 | 2026-02-09 | |
| 00841731137685 | TITANEX | TH20-44T-09 | 2026-02-09 | |
| 00841731137692 | TITANEX | TH20-46T-09 | 2026-02-09 | |
| 00841731137708 | TITANEX | TH20-48T-09 | 2026-02-09 |