Data / Medical devices / South Korea / Alpha AI Co., Ltd.

Alpha AI Co., Ltd.: FDA-registered device maker in PYEONGTAEK Gyeonggi, South Korea, 17 510(k) clearances

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

Alpha AI Co., Ltd. is registered with the FDA (registration 3004941535) in PYEONGTAEK Gyeonggi, South Korea. It lists 9 device types. The FDA files 17 510(k) clearances under its listings, the newest dated November 26, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004941535
Address: 154, Seotan-ro, Seotan-myeon, PYEONGTAEK Gyeonggi, South Korea, 17704
Owner or operator: Alpha AI Co., Ltd. (9036105)
Roles: Manufacturer
First device listed: October 17, 2005
Registered through: 2026
Brand names listed: 4 Hex Driver, Cannulated, 4CIS Augusta PEEK ALIF Cage; 4CIS Dunes PEEK DLIF Cage;, 4CIS Chiron Spinal Fixation System, 4CIS Marlin ACIF PEEK Cage, 4CIS Marlin Anterior Cervical Interbody Fusion Cage, 4CIS PEEK, PLIF and TLIF Cage System, 4CIS Pebble Beach PEEK PLIF Cage; 4CIS PEEK PLIF Cage;, 4CIS Pinehurst Anterior Cervical Plate System 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
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
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	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
November 26, 2024	K231655	4CIS® Chiron Spinal Fixation System	NKB	Substantially Equivalent	Solco Biomedical Co., Ltd.	accessdata.fda.gov
June 1, 2022	K203233	4CIS Chiron Spinal Fixation System	NKB	Substantially Equivalent	Solco Biomedical Co., Ltd.	accessdata.fda.gov
December 19, 2019	K192044	4CIS Marlin PEEK ACIF Cage	ODP	Substantially Equivalent	Solco Biomedical Co., Ltd.	accessdata.fda.gov
September 18, 2019	K190563	4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage	MAX	Substantially Equivalent	Solco Biomedical Co., Ltd.	accessdata.fda.gov
July 24, 2019	K190471	4CIS® Chiron Spinal Fixation System	NKB	Substantially Equivalent	Solco Biomedical Co., Ltd.	accessdata.fda.gov
January 16, 2019	K182489	4CIS® Pinehurst Anterior Cervical Plate system	KWQ	Substantially Equivalent	Solco Biomedical Co., Ltd.	accessdata.fda.gov
February 16, 2017	K162402	4CIS® Marlin ACIF Cage System	ODP	Substantially Equivalent	Solco Biomedical Co., Ltd.	accessdata.fda.gov
August 15, 2012	K121615	4CIS VANE SPINE SYSTEM	MNI	Substantially Equivalent	Solco Biomedical Co., Ltd.	accessdata.fda.gov
June 13, 2011	K102458	4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM	MNH	Substantially Equivalent	Solco Biomedical Co., Ltd.	accessdata.fda.gov
February 11, 2011	K101818	4CIS VANE SPINE SYSTEM	MNH	Substantially Equivalent	Solco Biomedical Co., Ltd.	accessdata.fda.gov
January 6, 2010	K092162	4CIS PEEK, PLIF AND TLIF CAGE SYSTEM	MAX	Substantially Equivalent	Solco Biomedical Co., Ltd.	accessdata.fda.gov
November 5, 2008	K081145	MODIFICATION TO 4CIS VANE SPINE SYSTEM	MNI	Substantially Equivalent	Solco Biomedical Co., Ltd.	accessdata.fda.gov
September 23, 2008	K082453	4CIS SOLAR AND APOLLON SPINE SYSTEMS	MNH	Substantially Equivalent	Solco Biomedical Co., Ltd.	accessdata.fda.gov
June 22, 2006	K060702	4CIS VANE SPINE SYSTEM	MNH	Substantially Equivalent	Solco Biomedical Co., Ltd.	accessdata.fda.gov
July 11, 2005	K051155	SOLCO 4CIS GENERAL PLATE SYSTEM	HRS	Substantially Equivalent	Solco Biomedical Co., Ltd.	accessdata.fda.gov
May 12, 2005	K050471	4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM	MNH	Substantially Equivalent	Solco Biomedical Co., Ltd.	accessdata.fda.gov
March 7, 2005	K043578	THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM	MNH	Substantially Equivalent	Solco Biomedical Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 26, 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.