KangLi
EUDAMEDFDA UDIClass IIb (EU MDR)
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-Pedicle Screw φ6.0×35mm FDA UDI
- Model / Reference
- Non-sterile Spinal Systems(KSS-II, III Lumbar) EUDAMEDT5816035 EUDAMEDFDA UDI
- Description
- KSS 6.0 U-Pedicle Screw φ6.0×35mm FDA UDI
Identifiers
- Catalog Number
- T5816035 FDA UDI
- Primary DI / UDI-DI
- 06937762171355 EUDAMEDFDA UDI
- Basic UDI-DI
- 690295900030FD EUDAMED
- Direct Marketing DI
- 06937762171355 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
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
Yes
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 35 Millimeter FDA UDI
Category: Spinal bone screw, non-bioabsorbable
KangLi by Suzhou Kangli Orthopaedics Instrument Co., Ltd. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 98848fb7-f1e5-403c-be03-76cef47c68c5 61 fields · synced May 30, 2026
- FDA UDI 4c3b40fe-4dc0-4286-ba0b-db89ff968337 37 fields · synced May 30, 2026