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Met One Technologies, LLC: FDA-registered device maker in El Paso, TX, United States, 7 510(k) clearances

Name: Met One Technologies, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Met One Technologies, LLC is registered with the FDA (registration 3012994232) in El Paso, TX, United States. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated May 20, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012994232
Address: 4519 Osborne Dr. Suite C, El Paso, TX, United States, 79922
Owner or operator: MET ONE TECHNOLOGIES, LLC (10052587)
Roles: Manufacturer, Specification developer
First device listed: August 22, 2016
Registered through: 2026
Brand names listed: AUDERE C CERVICAL, AUDERE PL & TL, CZAR CERVICAL PLATE, KODIAK C CERVICAL, KODIAK PL & TL, XULTAN 5.5 PEDICLE SCREW SYSTEM

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Manufacturer, Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Manufacturer, Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Manufacturer, Specification developer	accessdata.fda.gov
Posterior Cervical Screw System	NKG	2	Specification developer	accessdata.fda.gov
Spinal Vertebral Body Replacement Device	MQP	2	Manufacturer, Specification developer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Manufacturer, Specification developer	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
May 20, 2025	K250866	Sovereign Posterior Cervical System	NKG	Substantially Equivalent	Met One Technologies, LLC	accessdata.fda.gov
May 26, 2023	K230851	Kodiak Lumbar Spacer System	MAX	Substantially Equivalent	Met One Technologies, LLC	accessdata.fda.gov
December 22, 2022	K222806	Kodiak C Spinal Implant System	ODP	Substantially Equivalent	Met One Technologies, LLC	accessdata.fda.gov
December 17, 2018	K180772	Met One Czar Anterior Cervical Plate System	KWQ	Substantially Equivalent	Met One Technologies	accessdata.fda.gov
May 2, 2017	K170108	Xultan 5.5 Pedicle Screw System	NKB	Substantially Equivalent	Met One Technologies	accessdata.fda.gov
November 9, 2016	K161649	Virtu C Spinal Implant System	ODP	Substantially Equivalent	Met 1 Technologies, LLC	accessdata.fda.gov
August 1, 2016	K160699	VIRTU Lumbar Spacer System	MAX	Substantially Equivalent	Met 1 Technologies, LLC	accessdata.fda.gov

Compare with other makers

Updated May 20, 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.