Identity
- Trade Name
- VELOX FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- VELOX Fixed Angle Cervical Screw 4.5mm 16mm FDA UDI
- Model / Reference
- VFS2-4516 FDA UDI
- Description
- VELOX Fixed Angle Cervical Screw 4.5mm 16mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- M824VFS245161 FDA UDI
- 510(k) Number
- K131521 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Velox by Spinecraft Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K131521 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
- Spinecraft Llc
Sources (1)
- FDA UDI 86e8ca18-cffd-4373-a2a9-7d60426bb1a7 36 fields · synced May 31, 2026