Data / Medical devices / China / SHANGHAI KiNETIC MEDICAL CO LTD

SHANGHAI KiNETIC MEDICAL CO LTD: FDA-registered device maker in Shanghai, China, 1 510(k) clearance

Name: SHANGHAI KiNETIC MEDICAL CO LTD FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

SHANGHAI KiNETIC MEDICAL CO LTD is registered with the FDA (registration 3010071016) in Shanghai, China. It lists 19 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 17, 2012. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010071016
Address: 2F, No.23 Building, 528 Ruiqing Road, East Zhangjiang High-Tech Park; No.508, Tianchen Rd., Xianghuaqiao Street, Qingpu, Shanghai, China, 201201
Owner or operator: Shanghai Kinetic Medical Co LTD (10050980)
Roles: Contract manufacturer, Manufacturer
First device listed: January 22, 2016
Registered through: 2026
Brand names listed: Bone Biopsy Device, Bone Drill, Cannula, Chisel, Coaxial Step Dilator, Cup Forceps, Curette, Dilator and more

Devices it lists

Device	Product code	Class	Role	Source
Arthroscope	HRX	2	Manufacturer	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Cement, Bone, Vertebroplasty	NDN	2	Manufacturer	accessdata.fda.gov
Chisel, Surgical, Manual	FZO	1	Contract manufacturer	accessdata.fda.gov
Curette, Surgical, General Use	FZS	1	Contract manufacturer	accessdata.fda.gov
Device, Percutaneous, Biopsy	MJG	1	Manufacturer	accessdata.fda.gov
Dilator, Catheter	GCC	1	Contract manufacturer	accessdata.fda.gov
Dissector, Surgical, General & Plastic Surgery	GDI	1	Contract manufacturer	accessdata.fda.gov
Elevator, Surgical, General & Plastic Surgery	GEG	1	Contract manufacturer	accessdata.fda.gov
Handle, Scalpel	GDZ	1	Contract manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Contract manufacturer	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Manufacturer	accessdata.fda.gov
Passer, Wire, Orthopedic	HXI	1	Contract manufacturer	accessdata.fda.gov
Probe	HXB	1	Contract manufacturer	accessdata.fda.gov
Pusher, Socket	HXO	1	Contract manufacturer	accessdata.fda.gov
Retractor	GAD	1	Contract manufacturer	accessdata.fda.gov
Rongeur	HTX	1	Contract manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Contract manufacturer	accessdata.fda.gov
Trephine	HWK	1	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
September 17, 2012	K113742	KMC KYPHOPLASTY SYSTEM	NDN	Substantially Equivalent	Shanghai Kinetic Medical Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 17, 2012. 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.