Identity
- Trade Name
- Solitaire®-C Cervical Spacer FDA UDI
- Generic Name
- Vertebral body prosthesis FDA UDI
- Model / Reference
- 14-520586 FDA UDI
Identifiers
- Catalog Number
- 14-520586 FDA UDI
- Primary DI / UDI-DI
- 00880304909342 FDA UDI
- FDA Product Code
- OVE FDA UDI
- GMDN Term
- Vertebral body prosthesis 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vertebral body prosthesis
Solitaire®-C Cervical Spacer by Biomet Spine Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Biomet Spine Llc
Sources (1)
- FDA UDI da02a10b-fa6c-40d9-a343-3a538faa309a 35 fields · synced Jun 8, 2026