Identity
- Trade Name
- Cross-Fuse PEEK IBF System FDA UDI
- Generic Name
- Vertebral body prosthesis FDA UDI
- Device Name
- .VBR, Crossfuse, 13x14x50x0 spacer FDA UDI
- Model / Reference
- 35-1450-13 FDA UDI
- Description
- .VBR, Crossfuse, 13x14x50x0 spacer FDA UDI
Identifiers
- Catalog Number
- 35-1450-13 FDA UDI
- Primary DI / UDI-DI
- 00846468034337 FDA UDI
- FDA Product Code
- MQP FDA UDIMAX FDA UDIODP FDA UDI
- GMDN Term
- Vertebral body prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI888.3080 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
Cross-Fuse PEEK 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 12081534-6148-4c04-9b7f-1d857a4ebaac 36 fields · synced Jun 1, 2026