Identity
- Trade Name
- Valeo Spacer System FDA UDI
- Generic Name
- Internal spinal fixation procedure kit, reusable FDA UDI
- Device Name
- Paddle Distractor, 15mm FDA UDI
- Model / Reference
- K FDA UDI
- Description
- Paddle Distractor, 15mm FDA UDI
Identifiers
- Catalog Number
- 91.001.3215 FDA UDI
- Primary DI / UDI-DI
- M555910013215 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
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 c68c16ac-3442-405d-ac56-f39eb1be43e9 36 fields · synced May 30, 2026