KangLi Locking Plates System

FDA UDI

Class II (US FDA UDI)

by Suzhou Kangli Orthopaedics Instrument Co., Ltd.

Identity

Trade Name: KangLi Locking Plates System FDA UDI
Generic Name: Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Device Name: Tibial Locking Plates 10 holes FDA UDI
Model / Reference: T4071010 FDA UDI
Description: Tibial Locking Plates 10 holes FDA UDI

Identifiers

Catalog Number: T4071010 FDA UDI
Primary DI / UDI-DI: 06937762166511 FDA UDI
510(k) Number: K133840 FDA UDI
FDA Product Code: HWC FDA UDI
HRS FDA UDI
GMDN Term: Orthopaedic fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

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 — 191 Millimeter FDA UDI

Category: Orthopaedic fixation plate, non-bioabsorbable

KangLi Locking Plates System by Suzhou Kangli Orthopaedics Instrument Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthopaedic fixation plate, non-bioabsorbable.

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ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II

Cleared under the same submission

K133840 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
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 (1)

FDA UDI 86e20cb6-e228-4b27-80b1-8c142887fc47 36 fields · synced Jun 7, 2026