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KangLi
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref T6216050Model Non-sterile Spinal Systems(KSS-II, III Lumbar)
Identity
- Trade Name
- KangLi EUDAMEDKangLi Pedicle Screw Spinal System FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- Non-sterile Spinal Systems EUDAMEDKSS 5.5 U-Pedicle Screw φ6.0×50mm FDA UDI
- Model / Reference
- Non-sterile Spinal Systems(KSS-II, III Lumbar) EUDAMEDT6216050 EUDAMEDFDA UDI
- Description
- KSS 5.5 U-Pedicle Screw φ6.0×50mm FDA UDI
Identifiers
- Catalog Number
- T6216050 FDA UDI
- Primary DI / UDI-DI
- 06937762182122 EUDAMEDFDA UDI
- Basic UDI-DI
- 690295900030FD EUDAMED
- Direct Marketing DI
- 06937762182122 EUDAMED
- 510(k) Number
- K140053 FDA UDI
- FDA Product Code
- MNH FDA UDIMNI FDA UDI
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
Yes
EUDAMED
Sutures
Yes
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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 50 Millimeter FDA UDI
KangLi by Suzhou Kangli Orthopaedics Instrument Co., Ltd. — Class IIb — 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 | 690295900030FD | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Suzhou Kangli Orthopaedics Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000016075
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 49b67abe-c70f-43ec-8fe1-968668d29191 61 fields · synced May 30, 2026
- FDA UDI d79828bc-8918-4d91-98b4-6960b4e0eb66 36 fields · synced May 30, 2026