KangLi Pedicle Screw Spinal System T6290080
by Suzhou Kangli Orthopaedics Instrument Co., Ltd. EUDAMEDGUDID
Active
Ref T6290080Model Non-sterile Spinal Systems(Crosslink)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number690295900031FF | Date25 Aug 2023 | StatusActive |
| United States | GUDID listing GUDID | Number06937762181996 | Date3 Sep 2016 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Trade Name
- KangLi EUDAMEDKangLi Pedicle Screw Spinal System GUDID
- Generic Name
- Bone-screw internal spinal fixation system connector
- Device Name
- Non-sterile Spinal Systems
- Model / Ref / Catalog
- T6290080, Non-sterile Spinal Systems(Crosslink)
- Description
- EF 5.5 Crosslinks 80mm
- Primary DI / UDI-DI
- 06937762181996
- Basic UDI-DI
- 690295900031FF
- Direct Marketing DI
- 06937762181996
- 510(k) Number
- FDA Product Code
- MNH, MNI
- EMDN Code
- P09070304 Spine fixation system connectors
- GMDN Term
- Bone-screw internal spinal fixation system connector
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 888.3070
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
- Size
- Length — 80 Millimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIb | Class II |
| Sterile | No | Yes |
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Properties
Other properties (18)
- Reusable: No
- Contains Latex: No
- 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
- Serial Number: No
- Expiration Date: No