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Double Medical Technology Inc.: FDA-registered device maker in Xiamen Fujian, China, 14 510(k) clearances

Name: Double Medical Technology Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Double Medical Technology Inc. is registered with the FDA (registration 3010440433) in Xiamen Fujian, China. It lists 14 device types. The FDA files 14 510(k) clearances under its listings, the newest dated November 18, 2025. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this one Watch Double Medical Technology Inc.

FDA registration number: 3010440433
Address: No. 18, Shanbianhong East Road Haicang District, Xiamen Fujian, China, 361026
Owner or operator: Double Medical Technology Inc. (10045395)
Roles: Contract manufacturer, Manufacturer
First device listed: November 12, 2013
Registered through: 2026
Brand names listed: 0.9mm x 100mm K-wire, 1.4mm ClearnIng WIre, 1.4mm x 150mm K-wIre, 1.5 Case Cover, 1.5mm screw case, 1.6mm * 180mm K-wire, 2 Case Cover, 2.2mm x 250mm K-wIre and more

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Spinal Interlaminal	KWP	2	Manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Manufacturer	accessdata.fda.gov
Growing Rod System	PGM	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Manufacturer	accessdata.fda.gov
Passer, Wire, Orthopedic	HXI	1	Contract manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Manufacturer	accessdata.fda.gov
Posterior Cervical Screw System	NKG	2	Manufacturer	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Manufacturer	accessdata.fda.gov
Template	HWT	1	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
November 18, 2025	K252729	Universal Spinal System	NKB	Substantially Equivalent	Double Medical Technology, Inc.	accessdata.fda.gov
December 4, 2024	K242348	Locking Screw,CoCrMo	HWC	Substantially Equivalent	Double Medical Technology, Inc.	accessdata.fda.gov
November 22, 2023	K233078	Posterior Cervical Spine System	NKG	Substantially Equivalent	Double Medical Technology, Inc.	accessdata.fda.gov
March 14, 2023	K223753	Cervical Plate System	KWQ	Substantially Equivalent	Double Medical Technology, Inc.	accessdata.fda.gov
January 25, 2023	K221150	Advanced Bone Plate	HRS	Substantially Equivalent	Double Medical Technology, Inc.	accessdata.fda.gov
January 18, 2023	K221088	Anatomic Bone Plate	HRS	Substantially Equivalent	Double Medical Technology, Inc.	accessdata.fda.gov
January 10, 2023	K221090	Metal Cannulated Screw	HWC	Substantially Equivalent	Double Medical Technology, Inc.	accessdata.fda.gov
December 21, 2022	K221221	Advanced Intramedullary Nail System	HSB	Substantially Equivalent	Double Medical Technology, Inc.	accessdata.fda.gov
December 12, 2022	K220921	Metal Bone Screw	HWC	Substantially Equivalent	Double Medical Technology, Inc.	accessdata.fda.gov
August 24, 2018	K172830	Double Medical Femoral Nail System	HSB	Substantially Equivalent	Double Medical Technology, Inc.	accessdata.fda.gov
February 1, 2018	K172828	Double Medical Cage System	MAX	Substantially Equivalent	Double Medical Technology, Inc.	accessdata.fda.gov
August 22, 2016	K151458	Double Medical Universal Spine System	MNI	Substantially Equivalent	Double Medical Technology, Inc.	accessdata.fda.gov
May 21, 2014	K131609	DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM	HSB	Substantially Equivalent	Xiamen Double Engine Medical Material Co., Ltd.	accessdata.fda.gov
April 19, 2013	K130108	DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS	HRS	Substantially Equivalent	Xiamen Double Engine Medical Material Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 18, 2025. 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.