Suzhou Kangli Orthopaedics Instrument Co., Ltd.

Manufacturer and brand owner in Zhangjiagang, Jiangsu, China. 11 device types, 3 products catalogued, 3 clearances.

Registry build 21.09.26

Suzhou Kangli Orthopaedics Instrument Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Osteotome, Washer, Bolt Nut and 9 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2014.

11device types registered with the FDA
3products catalogued under its own name
3510(k) clearances

Registration

FDA registration record for Suzhou Kangli Orthopaedics Instrument Co., Ltd.
Registered name SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD.
Status Registered
Registration expires 2026
Registration number 3008749819
FEI number 3008749819
DUNS 527054774
Establishment type Contract manufacturer, Manufacturer

Chinese Registration

Chinese company register details for Suzhou Kangli Orthopaedics Instrument Co., Ltd.
Chinese legal name 苏州市康力骨科器械有限公司
Unified social credit code 91320582743110390H
Source NMPA UDI database

Location

Address of Suzhou Kangli Orthopaedics Instrument Co., Ltd.
City Zhangjiagang
Province Jiangsu
Address Nanyuan East Road, Tangqiao Town
Postal code 215600
Country China

What It Makes

Device types Suzhou Kangli Orthopaedics Instrument Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Fastener, Fixation, Nondegradable, Soft Tissue Class 2 2024 7
Orthosis, Spinal Pedicle Fixation Class 2 KangLi pedical screw spinal system 2014 13
Orthosis, Spondylolisthesis Spinal Fixation Class 2 KangLi pedical screw spinal system 2014 13
Osteotome Class 1 2024 9
Pin, Fixation, Smooth Class 2 2019 12
Plate, Fixation, Bone Class 2 Kangli Locking Plate System 2016 22
Prosthesis, Toe, Constrained, Polymer Class 2 2019 4
Rod, Fixation, Intramedullary And Accessories Class 2 2026 17
Screw, Fixation, Bone Class 2 Kangli Locking Plate System 2016 31
Staple, Fixation, Bone Class 2 2019 7
Washer, Bolt Nut Class 2 2025 9

Own-Brand Listings

Devices catalogued by Suzhou Kangli Orthopaedics Instrument Co., Ltd.
Product Code Catalogue numbers
KangLi Pedicle Screw Spinal System MNH 172
KangLi Locking Plates System HWC 8
KangLi Pedicle Screw Spinal System MNI 2

Clearances

510(k) clearances naming Suzhou Kangli Orthopaedics Instrument Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K142290 2014-11-24 MNH Traditional This company
K133840 2014-07-29 HRS Traditional This company
K140053 2014-06-26 MNH Traditional This company

From the Company

Published by the company on its own website, not by the FDA.

Information published by Suzhou Kangli Orthopaedics Instrument Co., Ltd.
Founded 1994
Factory area 40,000 square meters
Main products Trauma plates, Intramedullary nails, Spinal implants, Craniomaxillofacial implants
Certifications CE, FDA, ISO 13485, GMP
Export markets 40+ countries
OEM and ODM Offered

Nearby Manufacturers

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer