Identity
- Trade Name
- Titanex FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- Screw, Titanex Lag 4.0x40mm_Ti Jade FDA UDI
- Model / Reference
- T40-40T-14 FDA UDI
- Description
- Screw, Titanex Lag 4.0x40mm_Ti Jade FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841731106018 FDA UDI
- 510(k) Number
- K991197 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
Titanex by Vilex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.
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- QWIX — Newdeal Sas · Class II
- Monster Screw System — Paragon 28 · Class II
Cleared under the same submission
K991197 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Vilex, Inc.
Sources (1)
- FDA UDI b7a1543e-7070-4cb1-b5c8-79b31e3e8ba4 34 fields · synced May 31, 2026