Identity
- Trade Name
- C-PLUS™* PEEK VBR/IBF SYSTEM FDA UDI
- Generic Name
- Vertebral body prosthesis FDA UDI
- Device Name
- 14.5 X 17 X 7MM C-PLUS, VBR FDA UDI
- Model / Reference
- 30-C-1517-7 FDA UDI
- Description
- 14.5 X 17 X 7MM C-PLUS, VBR FDA UDI
Identifiers
- Catalog Number
- 30-C-1517-7 FDA UDI
- Primary DI / UDI-DI
- 00846468031428 FDA UDI
- FDA Product Code
- MAX FDA UDIODP FDA UDIMQP FDA UDI
- GMDN Term
- Vertebral body prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI888.3060 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
C-Plus™* Peek Vbr/Ibf System by Pioneer Surgical Technology, Inc. — 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
- Pioneer Surgical Technology, Inc.
Sources (1)
- FDA UDI f4cd978e-26f6-4b15-8a92-8bf7418c83b1 36 fields · synced Jun 8, 2026