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Vertebral Osteotome
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref V01103Model VO1101, VO1102, VO1103, VO1104, VO1105, VO1106, KMC-017-10
Identity
- Trade Name
- KMC Vertebral Osteotome FDA UDI
- Generic Name
- Bone access channel kit FDA UDI
- Device Name
- Vertebral Osteotome EUDAMEDKMC Vertebral Osteotome FDA UDI
- Model / Reference
- VO1101, VO1102, VO1103, VO1104, VO1105, VO1106, KMC-017-10 EUDAMEDV01103 EUDAMEDVO1103 FDA UDI
- Description
- KMC Vertebral Osteotome FDA UDI
Identifiers
- Catalog Number
- VO1103 FDA UDI
- Primary DI / UDI-DI
- 06938695501073 EUDAMEDFDA UDI
- Basic UDI-DI
- 69386955VOMB EUDAMED
- Direct Marketing DI
- 06938695501073 EUDAMED
- FDA Product Code
- LXH 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 I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 60 Centimeter FDA UDIPressure — 440 Pound per Square Inch FDA UDI
Vertebral Osteotome 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 | 69386955VOMB | 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-MF-000017688
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED 5df369fa-ca88-40a2-9b98-e6ce75ed84b9 61 fields · synced Oct 6, 2026
- FDA UDI 945a33a5-1bee-4f4e-bab5-ca59bb64c790 37 fields · synced May 30, 2026