Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008850074

FEI Number

3008850074

Entity Name

GS Solutions, Inc.

City/State/Country

Santa Ana, CA, US

Establishment Address

3210 S Susan St, Santa Ana, CA 92704, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

GS Solutions, Inc. (Owner Number: 10035190)

Owner / Operator Contact Address

3210 S Susan St, Santa Ana, CA 92704, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Screw System Cutting Forceps Sharp Guide wire - disp. instr. Blunt Guide wire - Disp. Instr. Target Needle - sterile Target Needle - MPM Impactor, Lumbar Impactor, Cervical Disc Shaver Cutting Trial Rod Length Gauge - Vorzeigen AnyPlus PEEK Lumbar Cages PYXIS 3D Titanium Cervical Cage System In situ Rod Bender, left/right - SIMS Coronal Bender, left/right - In'Tech Screw System Rod Clamp Pituitary, Posterior GSS Pedicle Screw System Shavers - SIMS MIS compressor/distractor - Vorzeigen compressor - PAK AnyPlus Implant Case GSS Implant Case AnyPlus Instrument Case Pedicle Standard Instrument Case GSS Instrument Case Obturator stylet AnyPlus Spinal Fixation System QUASAR Standalone ACIF Cage System Quasar Standalone ACIF Cage Guidewire drive with striker plate - Lowell Guidewire driver - Lowell Straight Osteotome Curved Osteotome AnyPlus Cervical PEEK Cage System AnyPlus PEEK Lumbar Fusion Cage Rasp, Straight Rasp, Curved Lumbar Cage Tamp Retractor holder set - Vorzeigen Soft Tissue Retractor - PAK Bifid Retractor - PAK Deflection Beam Torque Wrench - Gauthier GSS Counter Torque - SIMS Polyaxial locking driver - PAK AnyPlus PEEK Lumbar Fusion Cages Adapters Rod Reducer - Vorzeigen Distractor - PAK Shaft - In'Tech Rocker - In'Tech Torque Stabilizer - Vorzeigen EMG Sleeve - varied Handles, Straight and T - varied Tower - Lowell Wanding Blade - Vorzeigen Dilator - varied Pentalobe Tip - Teleflex Tapered wire probe - Lenox Bone Probe - Gauthier Bone Probe - Bradshaw

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2016-07-14
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-06-11
HWA	Impactor	Orthopedic	Class 1	888.4540	2012-06-11
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2016-07-14
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2012-06-11
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2016-07-14
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2024-09-03
HXW	Bender	Orthopedic	Class 1	888.4540	2012-06-11
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2016-07-14
HTX	Rongeur	Orthopedic	Class 1	888.4540	2016-07-14
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-07-14
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-07-14
HTO	Reamer	Orthopedic	Class 1	888.4540	2012-06-11
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2012-06-11
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-06-11
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-07-14
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2016-07-14
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-07-14
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-07-14
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-07-14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2016-07-14
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2024-09-03
GFC	Driver, Surgical, Pin	General, Plastic Surgery	Class 1	878.4820	2012-06-11
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2016-07-14
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2016-07-14
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2016-07-14
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2016-07-14
HXG	Tamp	Orthopedic	Class 1	888.4540	2016-07-14
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2012-06-11
HXC	Wrench	Orthopedic	Class 1	888.4540	2012-06-11
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2016-07-14
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-06-11
HXB	Probe	Orthopedic	Class 1	888.4540	2012-06-11

Official Correspondent

James (Hanjin) Shin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GS Solutions, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005596514	GS MEDICAL CO., LTD.	Heungdeok-gu, Cheongju-si Chungbuk, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K192492	Astura Medical, LLC	EL CAPITAN Anterior Lumber Interbody System	2020-04-21
K212498	Nexus Spine, LLC	Stable-L Standalone Lumbar Interbody System	2022-03-18
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2008	N/A	1	EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008850074. Last updated year: 2026. Please use registration number 3008850074 when referencing this establishment in official correspondence.