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KangLi
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref T5836545Model 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 6.0 U-Multi-Axial Break-Off Pedicle Screw φ6.5×45mm FDA UDI
- Model / Reference
- Non-sterile Spinal Systems(KSS-II, III Lumbar) EUDAMEDT5836545 EUDAMEDFDA UDI
- Description
- KSS 6.0 U-Multi-Axial Break-Off Pedicle Screw φ6.5×45mm FDA UDI
Identifiers
- Catalog Number
- T5836545 FDA UDI
- Primary DI / UDI-DI
- 06937762171768 EUDAMEDFDA UDI
- Basic UDI-DI
- 690295900030FD EUDAMED
- Direct Marketing DI
- 06937762171768 EUDAMED
- 510(k) Number
- K142290 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
- Not 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 — 45 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 7d72d9c1-d994-40ac-b738-b63323ab108c 61 fields · synced Aug 1, 2026
- FDA UDI 1e782939-3b7c-488e-9299-9f81d4911b74 37 fields · synced May 30, 2026