Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008749819

FEI Number

3008749819

Entity Name

SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD.

City/State/Country

Zhangjiagang City Jiangsu, CN

Establishment Address

Nanyuan East Road, Tangqiao Town, Zhangjiagang City Jiangsu 215600, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Suzhou Kangli Orthopaedics Instrument Co., Ltd. (Owner Number: 10047115)

Owner / Operator Contact Address

Nanyuan East Road, Tanggiao Town, Zhangjiagang City, Suzhou, CN-JS 215600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Kangli Locking Plate System KangLi pedical screw spinal system

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2019-05-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-05-07
KWH	Prosthesis, Toe, Constrained, Polymer	Orthopedic	Class 2	888.3720	2019-11-20
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2026-04-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-03-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-03-13
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2025-01-07
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2014-07-02
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2014-07-02
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-05-07
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-09-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-05-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-06-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-06-01

Official Correspondent

Jin Hua Huang

US Agent Details

GSX Import Email: FDA@gsximport.com Phone: (480) 6268177

Related Public Records

Same Entity

Suzhou Kangli Orthopaedics Instrument Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K895079	Buckman Co., Inc.	ACE BEADED K-WIRES ACE OLIVE WIRES	1989-09-13
K922193	Osteo AG	OSTEO KIRSCHNER WIRE	1992-07-23
K850026	Kirkstil Corp., Inc.	ORTHOPEDIC IMPLANT NAILS & PINS	1985-05-20
K963367	Rms Div.	RMS K-WIRE	1996-10-30
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-05	Biomet, Inc.	2	Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

Similar Registrations

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3006783837	STRUCTURE MEDICAL, LLC.	Naples, FL, US
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2029275	Sterigenics U.S., LLC	Corona, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008749819. Last updated year: 2026. Please use registration number 3008749819 when referencing this establishment in official correspondence.