Identity
- Trade Name
- Valeo Spacer System FDA UDI
- Generic Name
- Internal spinal fixation procedure kit, single-use FDA UDI
- Device Name
- Valeo II 9x25 0° PL Trials, 13mm FDA UDI
- Model / Reference
- C FDA UDI
- Description
- Valeo II 9x25 0° PL Trials, 13mm FDA UDI
Identifiers
- Catalog Number
- 91.113.3313 FDA UDI
- Primary DI / UDI-DI
- M555911133313 FDA UDI
- FDA Product Code
- ODP FDA UDIMAX FDA UDI
- GMDN Term
- Internal spinal fixation procedure kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Height — 13 Millimeter FDA UDIWidth — 25 Millimeter FDA UDILength — 9 Millimeter FDA UDI
Category: Internal spinal fixation procedure kit, single-use
The Valeo Spacer System is a high-quality, single-use internal spinal fixation procedure kit designed for orthopedic surgeons to facilitate precise bone-screw internal spinal fusion cage implantation procedures. With its versatile design and robust features, this device enables confident and effective treatment of various spinal conditions.
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Authorization Coverage (1 country)
Regulatory Authorizations
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 91940695-87b5-4ff5-90da-09c8b8698bd6 36 fields · synced Jul 8, 2026