Data / Medical devices / China / Suzhou Kangli Orthopaedics Instrument Co., Ltd.

Suzhou Kangli Orthopaedics Instrument Co., Ltd.: FDA-registered device maker in Zhangjiagang City Jiangsu, China, 3 510(k) clearances

Name: Suzhou Kangli Orthopaedics Instrument Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Suzhou Kangli Orthopaedics Instrument Co., Ltd. is registered with the FDA (registration 3008749819) in Zhangjiagang City Jiangsu, China. It lists 11 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 24, 2014. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3008749819
Address: Nanyuan East Road, Tangqiao Town, Zhangjiagang City Jiangsu, China, 215600
Owner or operator: Suzhou Kangli Orthopaedics Instrument Co., Ltd. (10047115)
Roles: Contract manufacturer, Manufacturer
First device listed: July 2, 2014
Registered through: 2027
Brand names listed: KangLi pedical screw spinal system, Kangli Locking Plate System

Devices it lists

Device	Product code	Class	Role	Source
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Contract manufacturer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Manufacturer	accessdata.fda.gov
Osteotome	HWM	1	Contract manufacturer	accessdata.fda.gov
Pin, Fixation, Smooth	HTY	2	Contract manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Prosthesis, Toe, Constrained, Polymer	KWH	2	Contract manufacturer	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Contract manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Contract manufacturer	accessdata.fda.gov
Washer, Bolt Nut	HTN	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 24, 2014	K142290	KangLi pedical screw spinal system	MNH	Substantially Equivalent	Suzhou Kangli Orthopaedics Instrument Co., Ltd.	accessdata.fda.gov
July 29, 2014	K133840	Kangli Locking Plate System	HRS	Substantially Equivalent	Suzhou Kangli Orthopaedics Instrument Co., Ltd.	accessdata.fda.gov
June 26, 2014	K140053	KANGLI PEDICLE SCREW SPINAL SYSTEM	MNH	Substantially Equivalent	Suzhou Kangli Orthopaedics Instrument Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 24, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.