Identity
- Trade Name
- Valencia Pedicle Screw System FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- 4.5mm x 35mm Multi-Axial Pedicle Screw FDA UDI
- Model / Reference
- 960-4535 FDA UDI
- Description
- 4.5mm x 35mm Multi-Axial Pedicle Screw FDA UDI
Identifiers
- Primary DI / UDI-DI
- B41796045351 FDA UDI
- FDA Product Code
- KWQ FDA UDIMNI FDA UDIKWP FDA UDIMNH FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI888.3070 FDA UDI888.3050 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 35 Millimeter FDA UDIOuter Diameter — 4.5 Millimeter FDA UDI
Valencia Pedicle Screw System by Altus Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Altus Spine
Sources (1)
- FDA UDI f754de9e-cac0-4113-83cb-1a922bcb2971 36 fields · synced May 31, 2026