Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005596514

FEI Number

3005596514

Entity Name

GS MEDICAL CO., LTD.

City/State/Country

Heungdeok-gu, Cheongju-si Chungbuk, KR

Establishment Address

90, Osongsaengmyeong 4-ro, Osong-eup,, Heungdeok-gu, Cheongju-si Chungbuk 28161, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GS Solutions, Inc. (Owner Number: 9080979)

Owner / Operator Contact Address

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

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K100516

PMA Number

N/A

All Registered Proprietary Names

Anyplus II T-Handle (Square) Scoli Set Screw Driver with I-Handle Driver Anyplus II Powerease Screw Driver Scoli Accessory Set Screw Final Driver Poly Quick Driver Anyplus Peek Cage System Retractor AnyPlus Spinal Fixation System (CoCr Rod) Anyplus II Navigation Awl Awl Anyplus II Awl PYXIS 3D Titanium Cervical Cage Instruments Tray Tray New Anyplus II Prebent Rod Caddy Anyplus II Implant Tray Anyplus II Instrument Tray (1/2) Universal Removal Set Tray Hex Male Quick Lock Trial Anyplus II Ball Tip Tester, Straight Scoli I-Ratchet Handle AnyPlus II Persuader Anyplus II Distractor OLIF II Tiral 3D OLIF II Thread Inserter Hex Female Rod Gripper Anyplus II Rod Holder 3D Cervical Cage 3D Printed Trial Hexalobe Male 3D Guide Inserter PULSAR Expandable PLIF Navigation Inserter Anyplus II Tab Breaker Navigation Fork Template Anyplus II Pediatric Rod Holder Anyplus II Rod Pusher (Straight Type) 3D Printed Expandable PLIF Trial 3D Cervical Cage Trial Anyplus II Ball Tip Tester, Curved Quasar Trial Without Stopper 3D Printed OLIF II Trial Anyplus Long Arm screw (Self, Conical) Dual AnyPlus Spinal Fixation System PYXIS 3D Titanium ALIF Cage PYXIS 3D Titanium Cage PYXIS 3D Titanium XTLIF Cage Anyplus II Navigation Tapper Anyplus II Navigation Longarm Tapper DL Nav Compatible Tap Tap Anyplus II Dual Lead Tap Anyplus II Powerease Tapper TRACKER Rasp Pulsar Expandable Cage System Anyplus II In-Situ Bender, Right Bender Anyplus II Rod Bender Anyplus II In-Situ Bender, Left Guide Wire Guide Hammer Anyplus II Navigation Poly Screw Driver Anyplus II Navigation Longarm Screw Driver Anyplus II Navigation Poly Reduction Screw Driver Anyplus II Set Screw Final Driver, 12N Scoli Crosslink Counter Torque Anyplus II Set Screw Starter, T-Type Anyplus II Cannulated Poly Screw Driver Anyplus II Cannulated Poly Reduction Screw Driver Anyplus II Set Screw Starter, Dual Driver Anyplus II Head Adjuster Anyplus II Set Screw Driver, T-Handle stylet Gauge Clamp Rongeur Pituitary QUASAR Standalone ACIF System GSS Pedicle screw system Extended Crosslink Reamer Distractor Anyplus II Anti-Torque Wrench Wrench PYXIS 3D Cervical Titanium Cage System QUASAR 3D Titanium Standalone ACIF System Impactor Anyplus II Spianl Fixation System Tracker Plus Curved Kit Dispenser kit (Cement Dispenser Kit, Inflation Device, Cement Mixing System) AnyPlus® Cervical PEEK Cage System Compressor/Distractor - Vorzeigen Anyplus II Compressor Osteotome Anyplus PEEK Cage System ALIF AnyPLUS PEEK Lumbar Cages

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GFC	Driver, Surgical, Pin	General, Plastic Surgery	Class 1	878.4820	2011-04-01
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2022-10-17
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2011-04-01
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2017-11-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2017-11-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-11-28
HWJ	Awl	Orthopedic	Class 1	888.4540	2011-04-01
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2011-04-12
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2006-02-14
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2010-01-26
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2010-01-26
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2010-01-26
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2010-01-26
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2010-01-26
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-05-02
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2011-04-01
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2019-12-23
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2019-12-23
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2010-12-13
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-10-17
HXW	Bender	Orthopedic	Class 1	888.4540	2011-04-01
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2011-04-01
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2011-04-01
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-08-23
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2011-04-01
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-11-19
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2011-04-01
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2011-04-01
HTX	Rongeur	Orthopedic	Class 1	888.4540	2013-02-05
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2023-07-23
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2006-02-14
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2006-02-14
HTO	Reamer	Orthopedic	Class 1	888.4540	2010-12-13
HXC	Wrench	Orthopedic	Class 1	888.4540	2011-04-01
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2024-10-16
HWA	Impactor	Orthopedic	Class 1	888.4540	2010-12-13
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-04-23
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2024-04-23
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-04-23
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2021-11-01
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2021-11-01
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2016-06-24
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2016-07-14
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2013-02-05
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2014-04-23
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2010-12-13

Official Correspondent

No official correspondent registered.

US Agent Details

James Shin Business: GS SOLUTIONS, INC. Email: jshin@gsmedicalusa.com Phone: (949) 3806385

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
3008850074	GS Solutions, Inc.	Santa Ana, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09
K122085	Omni Surgical, LP Dba Spine360	STINGRAY CERVICAL CAGE	2012-10-17
K120275	Synthes (Usa), LLC	SYNTHES ACIS/VERTEBRAL SPACER CR	2012-05-25
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0036-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013	Medtronic Sofamor Danek USA Inc	2	PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05	Zimmer Spine, Inc.	2	ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005596514. Last updated year: 2026. Please use registration number 3005596514 when referencing this establishment in official correspondence.