Identity
- Trade Name
- Valeo Spacer System FDA UDI
- Generic Name
- Ceramic spinal interbody fusion cage FDA UDI
- Device Name
- Valeo II TL, Round, 11x30, 8° , 10mm FDA UDI
- Model / Reference
- B FDA UDI
- Description
- Valeo II TL, Round, 11x30, 8° , 10mm FDA UDI
Identifiers
- Catalog Number
- 12.400.1010 FDA UDI
- Primary DI / UDI-DI
- M555124001010 FDA UDI
- FDA Product Code
- MAX FDA UDIODP 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
- Outer Diameter — 10 Millimeter FDA UDIWidth — 30 Millimeter FDA UDILength — 11 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 0db8cadd-0fd4-4966-ab96-45418a0f7c0c 37 fields · synced Jun 1, 2026