KangLi

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref T6235540Model Non-sterile Spinal Systems(KSS-II, III Lumbar)

by Suzhou Kangli Orthopaedics Instrument Co., Ltd.

Identity

Trade Name: KangLi EUDAMED
KangLi Pedicle Screw Spinal System FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: Non-sterile Spinal Systems EUDAMED
KSS 5.5 U-Multi-Axial Break-Off Pedicle Screw φ5.5×40mm FDA UDI
Model / Reference: Non-sterile Spinal Systems(KSS-II, III Lumbar) EUDAMED
T6235540 EUDAMEDFDA UDI
Description: KSS 5.5 U-Multi-Axial Break-Off Pedicle Screw φ5.5×40mm FDA UDI

Identifiers

Catalog Number: T6235540 FDA UDI
Primary DI / UDI-DI: 06937762182443 EUDAMEDFDA UDI
Basic UDI-DI: 690295900030FD EUDAMED
Direct Marketing DI: 06937762182443 EUDAMED
510(k) Number: K140053 FDA UDI
FDA Product Code: MNH FDA UDI
MNI FDA UDI
EMDN Code: P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
GMDN Term: Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

Yes

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 40 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.

4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II

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 d8d1d14b-bf0c-4ee6-9687-06506fd93baf 61 fields · synced Aug 1, 2026
FDA UDI dec77ec2-298f-4b8a-895f-13c14a980de6 36 fields · synced May 30, 2026