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Kyphoplasty System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref FG0007-20Model FG0007-10, FG0007-15, FG0007-20Ref FG0005-10Model FG0005-10, FG0005-15, FG0005-20
Identity
- Trade Name
- Kyphoplasty System EUDAMEDKMC Kyphoplasty System FDA UDI
- Generic Name
- Balloon kyphoplasty kit FDA UDI
- Device Name
- Kyphoplasty Procedure Pack EUDAMEDKMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit Puncture Needle KMC Medical Balloon Catheter Syringe Pump FDA UDI
- Model / Reference
- FG0007-10, FG0007-15, FG0007-20 EUDAMEDFG0007-20 EUDAMEDFG0005-10, FG0005-15, FG0005-20 EUDAMEDFG0005-10 EUDAMEDFDA UDI
- Description
- KMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit Puncture Needle KMC Medical Balloon Catheter Syringe Pump FDA UDI
Identifiers
- Catalog Number
- FG0005-10 FDA UDI
- Primary DI / UDI-DI
- 06938695500243 EUDAMED06938695501523 EUDAMEDFDA UDI
- Basic UDI-DI
- 69386955PKPVIIAX EUDAMED69386955PKPV6Q EUDAMED
- 510(k) Number
- K113742 FDA UDI
- FDA Product Code
- NDN FDA UDIHRX FDA UDI
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
- GMDN Term
- Balloon kyphoplasty kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3027 FDA UDI888.1100 FDA UDI
- Medical Purpose
- The KMC Kyphoplasty System is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA 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
Yes
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
Yes
FDA UDI
Kyphoplasty System by Shanghai Kinetic Medical Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69386955PKPVIIAX | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shanghai Kinetic Medical Co., Ltd.
- EUDAMED SRN
- CN-PR-000040949
Sources (3)
- EUDAMED 65ed5805-d255-4b7e-a8ef-f14503498078 61 fields · synced Oct 6, 2026
- EUDAMED ca927520-cd39-476e-9c15-56ef9f365029 61 fields · synced May 18, 2026
- FDA UDI aa8f5cab-242c-4a46-b884-9b68ef1c0793 37 fields · synced May 30, 2026