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Kyphoplasty Tool Kit
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref FG2001Model FG2001, FG2002, FG2003, FG2004, FG2005, FG2002M, FG2006M, FG2007M
Identity
- Trade Name
- Kyphoplasty Tool Kit EUDAMEDTool Kit FDA UDI
- Generic Name
- Bone access channel 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
- FG2001, FG2002, FG2003, FG2004, FG2005, FG2002M, FG2006M, FG2007M EUDAMEDFG2001 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
- Primary DI / UDI-DI
- 06938695520012 EUDAMEDFDA UDI
- Basic UDI-DI
- 69386955KTIAP 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
- Bone access channel kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3027 FDA UDI888.1100 FDA UDI
- Medical Purpose
- The Kyphoplasty Tool Kit is intended to establish the working pathway and inject bone cement during minimally invasive procedures, such as vertebroplasty or 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 Tool Kit 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 | 69386955KTIAP | 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 (2)
- EUDAMED c3eefb90-6115-4f89-a42e-d1fe68dc83ab 61 fields · synced Oct 7, 2026
- FDA UDI c0e18e91-d508-478d-8188-9c148b9eed52 35 fields · synced May 29, 2026