Identity
- Trade Name
- RENOVA SPINE BALLOON CATHETER EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Kyphoplasty balloon catheter FDA UDI
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMEDRENOVA SPINE BALLOON CATHETER EUDAMEDREDUCTION AND FIXATION OF FRACTURES AND/OR CREATION OF A VOID IN CANCELLOUS BONE IN THE SPINE DURING BALLOON KYPHOPLASTY (FOR USE WITH CLEARED SPINAL POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENTS) FDA UDI
- Model / Reference
- RESB15J EUDAMEDRENOVA SPINE BALLOON CATHETER FDA UDI
- Description
- REDUCTION AND FIXATION OF FRACTURES AND/OR CREATION OF A VOID IN CANCELLOUS BONE IN THE SPINE DURING BALLOON KYPHOPLASTY (FOR USE WITH CLEARED SPINAL POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENTS) FDA UDI
Identifiers
- Catalog Number
- RESB15J FDA UDI
- Primary DI / UDI-DI
- 08033860023980 EUDAMEDFDA UDI
- Basic UDI-DI
- 8033860KYPFT05A9T EUDAMEDB-08033860023980 EUDAMED
- 510(k) Number
- K231340 FDA UDI
- FDA Product Code
- HRX FDA UDINDN FDA UDI
- EMDN Code
- K010301 SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON EUDAMED
- GMDN Term
- Kyphoplasty balloon catheter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.1100 FDA UDI888.3027 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Dimensions & Sizes
- Size
- Needle Gauge — 11 Gauge FDA UDIBalloon Length — 15 Millimeter FDA UDI
Renova Spine Balloon Catheter by Biopsybell Srl — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 8033860KYPFT05A9T | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8033860KYPFT05A9T | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (3)
- EUDAMED e4d06015-2a4d-4001-be77-8e748e35700f 61 fields · synced Jun 19, 2026
- EUDAMED 84b5443d-7ca5-4f33-adc4-9d2933bc406e 61 fields · synced May 19, 2026
- FDA UDI e1c922ee-fd38-423a-a241-d52c7ed1df37 37 fields · synced May 30, 2026