Identity
- Trade Name
- Valeo Spacer System FDA UDI
- Generic Name
- Internal spinal fixation procedure kit, reusable FDA UDI
- Device Name
- Rasp 16x12, 6°, 11mm FDA UDI
- Model / Reference
- D FDA UDI
- Description
- Rasp 16x12, 6°, 11mm FDA UDI
Identifiers
- Catalog Number
- 91.002.2211 FDA UDI
- Primary DI / UDI-DI
- M555910022211 FDA UDI
- FDA Product Code
- ODP FDA UDIMAX FDA UDI
- GMDN Term
- Internal spinal fixation procedure kit, reusable 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Dimensions & Sizes
- Size
- Height — 11 Millimeter FDA UDIWidth — 12 Millimeter FDA UDILength — 16 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Amedica Corp.
Sources (1)
- FDA UDI 0d181d24-9624-4dd3-aab0-e0735c5c0085 37 fields · synced May 31, 2026