Identity
- Trade Name
- Valeo Spacer System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, sterile FDA UDI
- Device Name
- Valeo Corpectomy Trials, 16x12mm, 0º , 27mm FDA UDI
- Model / Reference
- B FDA UDI
- Description
- Valeo Corpectomy Trials, 16x12mm, 0º , 27mm FDA UDI
Identifiers
- Catalog Number
- 91.009.6427 FDA UDI
- Primary DI / UDI-DI
- M555910096427 FDA UDI
- FDA Product Code
- ODP FDA UDIMAX FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, sterile 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
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 — 27 Millimeter FDA UDIWidth — 12 Millimeter FDA UDILength — 16 Millimeter FDA UDI
Category: Bone-screw internal spinal fixation system, sterile
Valeo Spacer System by Amedica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system, sterile.
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- Mont Blanc MIS Spinal Systems — Spineway SA · Class II
- ROMEO Posterior Osteosynthesis system — Spineart · Class II
- VERTICALE — Silony Medical GmbH · Class II
- Mont Blanc MIS Spinal Systems — Spineway SA · Class II
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 08244d4e-dc9d-4829-ae59-4047ac0d7390 36 fields · synced Jun 8, 2026