Identity
- Trade Name
- Valeo Spacer System FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- Valeo PS Screw, ø4.5mm x 55mm, Long FDA UDI
- Model / Reference
- C FDA UDI
- Description
- Valeo PS Screw, ø4.5mm x 55mm, Long FDA UDI
Identifiers
- Catalog Number
- 11.007.4555 FDA UDI
- Primary DI / UDI-DI
- M555110074555 FDA UDI
- FDA Product Code
- MNH FDA UDINKB FDA UDIMNI FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 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 — 4.5 Millimeter FDA UDILength — 55 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 ddf5ade6-d550-4281-a2c5-6076594f2fd7 37 fields · synced Jun 1, 2026