Identity
- Trade Name
- Quantum BacFuse Spinous Process Fusion Plate FDA UDI
- Generic Name
- Bone file/rasp, manual, reusable FDA UDI
- Device Name
- Rasp FDA UDI
- Model / Reference
- 83-RASP-16 FDA UDI
- Description
- Rasp FDA UDI
Identifiers
- Catalog Number
- 83-RASP-16 FDA UDI
- Primary DI / UDI-DI
- 00846468002800 FDA UDI
- FDA Product Code
- HTR FDA UDI
- GMDN Term
- Bone file/rasp, manual, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
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
Quantum BacFuse Spinous Process Fusion Plate by Pioneer Surgical Technology, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Pioneer Surgical Technology, Inc.
Sources (1)
- FDA UDI c61f1ba7-40e2-4f56-8eda-87f5c4cf55b3 36 fields · synced Jun 1, 2026