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Artfx Medical LLC: FDA-registered device maker in Jax, FL, United States, 6 510(k) clearances

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

Artfx Medical LLC is registered with the FDA (registration 3017435639) in Jax, FL, United States. It lists 17 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 2, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3017435639
Address: 50 n laura st 25th floor, Jax, FL, United States, 32202
Owner or operator: ARTFX MEDICAL LLC (10077845)
Roles: Manufacturer for export, Repackager or relabeler
First device listed: January 24, 2021
Registered through: 2026
Brand names listed: ARTFX ARTHROSCOPY, ARTFX CEMENT, ARTFX Lumbar Cages, ARTFX NAIL SYSTEM, ARTFX SPINAL FIXATION SYSTEM, ARTFX SPINAL SYSTEM, ARTFX SPINE INSTRUMENT, ARTFX TRAUMA INSTRUMENT and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Repackager or relabeler	accessdata.fda.gov
Accessories, Fixation, Spinal Intervertebral Body	LYQ	1	Repackager or relabeler	accessdata.fda.gov
Appliance, Fixation, Spinal Interlaminal	KWP	2	Repackager or relabeler	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Repackager or relabeler	accessdata.fda.gov
Dispenser, Cement	KIH	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Bending Or Contouring	HXP	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Compression	HWN	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Surgical, Non-Powered	HAO	1	Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Repackager or relabeler	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Repackager or relabeler	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Repackager or relabeler	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Repackager or relabeler	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Repackager or relabeler	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Repackager or relabeler	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Repackager or relabeler	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Repackager or relabeler	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Repackager or relabeler	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
October 2, 2024	K240889	ARTFX Lumbar PEEK Cages	MAX	Substantially Equivalent	Artfx Medical	accessdata.fda.gov
June 28, 2024	K240893	ARTFX MEDICAL Cervical PEEK Cages	ODP	Substantially Equivalent	Artfx Medical	accessdata.fda.gov
April 20, 2023	K212220	ArtFX Spinal Fixation System	NKB	Substantially Equivalent	Artfx Medical, LLC	accessdata.fda.gov
December 17, 2015	K151062	WASTON Metallic Intramedullary Nail System	HSB	Substantially Equivalent	Changzhou Waston Medical Appliance Co., Ltd.	accessdata.fda.gov
November 18, 2015	K150684	WASTON General Spinal System	MNI	Substantially Equivalent	Changzhou Waston Medical Appliance Co., Ltd.	accessdata.fda.gov
August 10, 2015	K151057	WASTON Metallic Bone Plate and Screw Systems	HRS	Substantially Equivalent	Changzhou Waston Medical Appliance Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated October 2, 2024. 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.