Identity
- Trade Name
- Valeo Spacer System FDA UDI
- Generic Name
- Ceramic spinal interbody fusion cage FDA UDI
- Device Name
- Valeo II LL - 22x50, 6°, 8mm FDA UDI
- Model / Reference
- A FDA UDI
- Description
- Valeo II LL - 22x50, 6°, 8mm FDA UDI
Identifiers
- Catalog Number
- 11.020.6008 FDA UDI
- Primary DI / UDI-DI
- M555110206008 FDA UDI
- FDA Product Code
- ODP FDA UDIMAX FDA UDI
- GMDN Term
- Ceramic spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Dimensions & Sizes
- Size
- Height — 8 Millimeter FDA UDIWidth — 50 Millimeter FDA UDILength — 22 Millimeter FDA UDI
Valeo Spacer System by Amedica Corp. — 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
- Amedica Corp.
Sources (1)
- FDA UDI ebe65d6e-6119-49b2-a8d2-0309e1947d49 37 fields · synced May 31, 2026