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Shanghai Sanyou Medical Co. Ltd: FDA-registered device maker in Shanghai, China, 9 510(k) clearances

Name: Shanghai Sanyou Medical Co. Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shanghai Sanyou Medical Co. Ltd is registered with the FDA (registration 3011556898) in Shanghai, China. It lists 6 device types. The FDA files 9 510(k) clearances under its listings, the newest dated December 12, 2023. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3011556898
Address: 385 Huirong Rd, Jiading District, Shanghai, China, 201815
Owner or operator: Shanghai Sanyou Medical Co. LTD (10048121)
Roles: Manufacturer
First device listed: December 10, 2014
Registered through: 2026
Brand names listed: Adena-Zina, CLIF, Duetto, Katia System, Keystone/Halis/Dica/Lydia, Shanghai Sanyou CARMEN Cervical Fusion System, Shanghai Sanyou PEEK Cage System, Zeus

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Manufacturer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Manufacturer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	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
December 12, 2023	K230872	Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction Changeable Lumbar Cage System, KEYSTONE Cage System	MAX	Substantially Equivalent	Shanghai Sanyou Medical Co, Ltd.	accessdata.fda.gov
October 10, 2023	K230961	Zeus Spinal System	NKB	Substantially Equivalent	Shanghai Sanyou Medical Co, Ltd.	accessdata.fda.gov
July 28, 2023	K231931	Adena-Zina Spinal System	NKB	Substantially Equivalent	Shanghai Sanyou Medical Co, Ltd.	accessdata.fda.gov
September 21, 2021	K211689	KEYSTONE PEEK Cage System	MAX	Substantially Equivalent	Shanghai Sanyou Medical Co, Ltd.	accessdata.fda.gov
August 16, 2021	K212066	Adena-Zina System	NKB	Substantially Equivalent	Shanghai Sanyou Medical Co, Ltd.	accessdata.fda.gov
October 5, 2017	K163366	Shanghai Sanyou CARMEN Cervical Fusion System	KWQ	Substantially Equivalent	Shanghai Sanyou Medical Co, Ltd.	accessdata.fda.gov
September 18, 2017	K163422	Shanghai Sanyou PEEK Cage System	ODP	Substantially Equivalent	Shanghai Sanyou Medical Co, Ltd.	accessdata.fda.gov
February 12, 2016	K152781	Adena-Zina System	NKB	Substantially Equivalent	Shanghai Sanyou Medical Co, Ltd.	accessdata.fda.gov
August 7, 2013	K131512	KATIA SYSTEM	KWQ	Substantially Equivalent	Shanghai Sanyou Medical Co, Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 12, 2023. 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.