Data / Medical devices / United States / GS Solutions, Inc.

GS Solutions, Inc.: FDA-registered device maker in Santa Ana, CA, United States, 9 510(k) clearances

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

GS Solutions, Inc. is registered with the FDA (registration 3008850074) in Santa Ana, CA, United States. It lists 34 device types. The FDA files 9 510(k) clearances under its listings, the newest dated August 20, 2024. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch GS Solutions, Inc.

FDA registration number: 3008850074
Address: 3210 S Susan St, Santa Ana, CA, United States, 92704
Owner or operator: GS Solutions, Inc. (10035190)
Roles: Repackager or relabeler
First device listed: June 6, 2012
Registered through: 2026
Brand names listed: Adapters, AnyPlus Cervical PEEK Cage System, AnyPlus Implant Case, AnyPlus Instrument Case, AnyPlus PEEK Lumbar Cages, AnyPlus PEEK Lumbar Fusion Cage, AnyPlus PEEK Lumbar Fusion Cages, AnyPlus Spinal Fixation System and more

Devices it lists

Device	Product code	Class	Role	Source
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
Awl	HWJ	1	Repackager or relabeler	accessdata.fda.gov
Bender	HXW	1	Repackager or relabeler	accessdata.fda.gov
Clamp	HXD	1	Repackager or relabeler	accessdata.fda.gov
Curette	HTF	1	Repackager or relabeler	accessdata.fda.gov
Driver, Surgical, Pin	GFC	1	Repackager or relabeler	accessdata.fda.gov
Forceps	HTD	1	Repackager or relabeler	accessdata.fda.gov
Gauge, Depth	HTJ	1	Repackager or relabeler	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Repackager or relabeler	accessdata.fda.gov
Hammer, Surgical	FZY	1	Repackager or relabeler	accessdata.fda.gov
Impactor	HWA	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Compression	HWN	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Cutting, Orthopedic	HTZ	1	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
Intervertebral Fusion Device With Integrated Fixation, Cervical	OVE	2	Repackager or relabeler	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Lumbar	OVD	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
Osteotome	HWM	1	Repackager or relabeler	accessdata.fda.gov
Probe	HXB	1	Repackager or relabeler	accessdata.fda.gov
Rasp	HTR	1	Repackager or relabeler	accessdata.fda.gov
Reamer	HTO	1	Repackager or relabeler	accessdata.fda.gov
Retractor	GAD	1	Repackager or relabeler	accessdata.fda.gov
Rongeur	HTX	1	Repackager or relabeler	accessdata.fda.gov
Screwdriver	HXX	1	Repackager or relabeler	accessdata.fda.gov
Stylet, Surgical, General & Plastic Surgery	GAH	1	Repackager or relabeler	accessdata.fda.gov
Tamp	HXG	1	Repackager or relabeler	accessdata.fda.gov
Tap, Bone	HWX	1	Repackager or relabeler	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Repackager or relabeler	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Repackager or relabeler	accessdata.fda.gov
Wrench	HXC	1	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
August 20, 2024	K241738	PYXIS 3D Titanium Cervical Cage system	ODP	Substantially Equivalent	GS Medical Co., Ltd.	accessdata.fda.gov
February 9, 2023	K222041	CYGNUS-C Standalone ACIF System	OVE	Substantially Equivalent	GS Medical Co., Ltd.	accessdata.fda.gov
July 27, 2022	K221687	Pegasus-X Expandable PLIF System	MAX	Substantially Equivalent	GS Medical Co., Ltd.	accessdata.fda.gov
June 24, 2016	K153517	AnyPlus® Cervical PEEK Cage System	ODP	Substantially Equivalent	GS Medical Co., Ltd.	accessdata.fda.gov
April 18, 2014	K131612	ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGES	MAX	Substantially Equivalent	GS Medical Co., Ltd.	accessdata.fda.gov
October 17, 2011	K111354	GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)	MAX	Substantially Equivalent	GS Medical Co., Ltd.	accessdata.fda.gov
December 3, 2010	K100516	ANYPLUS PEEK CAGES	OVD	Substantially Equivalent	GS Medical Co., Ltd.	accessdata.fda.gov
January 25, 2010	K091717	ANY PLUS SPINAL FIXATION SYSTEM	NKB	Substantially Equivalent	GS Medical Co., Ltd.	accessdata.fda.gov
March 8, 2006	K053573	GSS PEDICLE SCREW SYSTEM	MNH	Substantially Equivalent	GS Medical Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 20, 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.