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KangLi Pedicle Screw Spinal System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref T6241300Model Non-sterile Spinal Systems(KSS-II, III Lumbar)
Identity
- Trade Name
- KangLi EUDAMEDKangLi Pedicle Screw Spinal System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system rod FDA UDI
- Device Name
- Non-sterile Spinal Systems EUDAMEDRod (φ5.5) FDA UDI
- Model / Reference
- Non-sterile Spinal Systems(KSS-II, III Lumbar) EUDAMEDT6241300 EUDAMEDT6240300 FDA UDI
- Description
- Rod (φ5.5) FDA UDI
Identifiers
- Catalog Number
- T6240300 FDA UDI
- Primary DI / UDI-DI
- 06937762172161 EUDAMEDFDA UDI
- Basic UDI-DI
- 690295900030FD EUDAMED
- Direct Marketing DI
- 06937762172161 EUDAMED
- 510(k) Number
- K140053 FDA UDI
- FDA Product Code
- MNH FDA UDIMNI FDA UDI
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
- GMDN Term
- Bone-screw internal spinal fixation system rod 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 — 300 Millimeter FDA UDI
Category: Bone-screw internal spinal fixation system rod
KangLi Pedicle Screw Spinal System by Suzhou Kangli Orthopaedics Instrument Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Bone-screw internal spinal fixation system rod.
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class II
- Proficient® Posterior Cervical Spine System — Spine Wave, Inc. · Class II
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
- The JASPER Spinal Fixation System60 — GBS Commonwealth Co., Ltd. · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
Cleared under the same submission
K140053 also covers:
- KangLi Pedicle Screw Spinal System — Suzhou Kangli Orthopaedics Instrument Co., Ltd.
- KangLi Pedicle Screw Spinal System — Suzhou Kangli Orthopaedics Instrument Co., Ltd.
- KangLi Pedicle Screw Spinal System — Suzhou Kangli Orthopaedics Instrument Co., Ltd.
- KangLi Pedicle Screw Spinal System — Suzhou Kangli Orthopaedics Instrument Co., Ltd.
- KangLi Pedicle Screw Spinal System — Suzhou Kangli Orthopaedics Instrument Co., Ltd.
- KangLi Pedicle Screw Spinal System — Suzhou Kangli Orthopaedics Instrument Co., Ltd.
- KangLi Pedicle Screw Spinal System — Suzhou Kangli Orthopaedics Instrument Co., Ltd.
- KangLi Pedicle Screw Spinal System — Suzhou Kangli Orthopaedics Instrument Co., Ltd.
- KangLi Pedicle Screw Spinal System — Suzhou Kangli Orthopaedics Instrument Co., Ltd.
- KangLi Pedicle Screw Spinal System — Suzhou Kangli Orthopaedics Instrument Co., Ltd.
- KangLi Pedicle Screw Spinal System — Suzhou Kangli Orthopaedics Instrument Co., Ltd.
- KangLi Pedicle Screw Spinal System — Suzhou Kangli Orthopaedics Instrument Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Suzhou Kangli Orthopaedics Instrument Co., Ltd.
Sources (2)
- FDA UDI 85142ca7-5740-43fb-9e8c-698b6d588d4d 36 fields · synced Oct 6, 2026
- EUDAMED d3da5ec3-6dfe-4add-be80-d3e8b74a7063 61 fields · synced Oct 6, 2026