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Talus Of Vilex (tov)
FDA 510(k)FDA UDIClass II (US FDA 510(k))
510(k) K041289
by Vilex, Inc.
Identity
- Trade Name
- Talus of Vilex (TOV) FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- TOV Implant 09mm_Ti Gold FDA UDI
- Model / Reference
- TOV2-09 FDA UDI
- Description
- TOV Implant 09mm_Ti Gold FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841731106551 FDA UDI
- 510(k) Number
- FDA Product Code
- HWC FDA 510(k)FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)FDA UDI
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
Talus Of Vilex (tov) by Vilex, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K041289 | Class II | Active |
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Manufacturer
- Manufacturer
- Vilex, Inc.
Sources (2)
- FDA 510(k) K041289 24 fields · synced Jun 19, 2026
- FDA UDI 742b35aa-21c4-41bc-b48a-97d916db5da3 34 fields · synced May 27, 2026