Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009554293

FEI Number

3009554293

Entity Name

CG MedTech USA, Inc.

City/State/Country

Irvine, CA, US

Establishment Address

41 Corporate Park Suite 200, Irvine, CA 92606, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

CG MedTech Co., Ltd. (Owner Number: 9045343)

Owner / Operator Contact Address

20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, KR-41 11781, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K140864

PMA Number

N/A

All Registered Proprietary Names

ANAX 5.5 CT SPINAL SYSTEM COMPRESSOR Retractor Velofix SA Cervical Cage UniSpace® TPLIF Cage Velofix TLIF Cage Velofix SA Cervical Cage Bone Impactor HOOK IMPACTOR Forceps ASPIRON S ACP System Reamer Drill Guide Holder(Plate,Hook,Rod,Housing,T-Lin Set Screw Guide Extended Set Screw Inserting Guide Guide Driver Poly Head Adjuster Temporary Fixation Pin Driver Alignment Guide LOCKING CAP DRIVER GUIDE PIN DRIVER HOUSING HOLDER TAP GUIDE SET SCREW DRIVER GUIDE ANTI TORQU ROD HOLDER ASPIRON S ACP SYSTEM Cannulated Tap Sharp Tap Adjustable Tap TAP-6.OMM TAP-4.5MM TAP-7MM TAP-7.5MM TAP-3.5MM TAP-8MM TAP-5.OMM TAP-4.OMM INNOVERSE Spinal System Velofix TLIF Cage ASPIRON ACP System ANAX OCT Spinal System Surgical Tray Awl Extended Awl Cannulated AWL ROD TEMPLATE 400MM ROD TEMPLATE 200MM Reduction Cutter Surgical Cutter ROD CUTTER REDUCTION HOUSING CUTTER DYNA LOCKING TROCHANTERIC NAIL Plate Bender Rod bender extended ROD BENDER IN-SITU ROD BENDER-RIGHT IN-SITU ROD BENDER-LEFT INNOVERSE Navigation Instruments DRILL BIT FOR D4 DRILL BIT FOR D3.5 MULTIPLE DRILL BITS ADJUSTABLE DRILL BITS Polarfix Facet Screw System Axial Torque Wrench 4 Hex Derotation Wrench Torque Wrench(GSFS,Transverse link) TORQUE WRENCH FOR T LINK-COLLET TYP AXIAL TORQUE WRENCH DEROTATOR Rasp ASPIRON S ACP System ANAX OCT Spinal System Probe Cannulated Probe Straight Guide Probe Sphere Handle Curved Probe Sphere Handle Probe Reaming Probe PROBE CURVED PROBE ANAX 5.5 SPINAL SYSTEM Slide hammer ROD PUSHER ANAX 5.5 Spinal System Velofix Interbody Fusion System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2018-12-17
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2005-01-18
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2006-07-28
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2021-11-21
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-12-03
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2019-07-10
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2017-12-07
HWA	Impactor	Orthopedic	Class 1	888.4540	2006-06-30
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-01-23
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-03-20
HTO	Reamer	Orthopedic	Class 1	888.4540	2010-12-31
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2005-01-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2018-09-11
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2005-01-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-02-12
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-12-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-12-27
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2018-12-27
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2018-12-27
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-01-23
HWJ	Awl	Orthopedic	Class 1	888.4540	2005-01-18
HWT	Template	Orthopedic	Class 1	888.4800	2005-01-18
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2005-01-18
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-05-16
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2023-05-16
HXW	Bender	Orthopedic	Class 1	888.4540	2005-01-18
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2015-09-03
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2005-01-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-07-07
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-07-07
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2006-07-28
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2018-01-09
HXC	Wrench	Orthopedic	Class 1	888.4540	2005-01-18
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2008-12-23
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-05-16
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-06-30
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2025-06-30
HXB	Probe	Orthopedic	Class 1	888.4540	2005-01-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-12-13
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2010-12-31
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	2005-01-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-12-17
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2014-07-31
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2014-07-31

Official Correspondent

Jae-Hong Kim

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CG MedTech Co., Ltd.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9617297	CG MedTech Co., Ltd.	Uijeongbu-si Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05
K252461	Spinal Resources, Inc.	Swedge Pedicle Screw Fixation System Bezier Rod	2026-01-13
K140696	Pioneer Surgical Technology, Inc.	STREAMLINE TL SPINAL FIXATION SYSTEM	2014-04-10
K141398	Medicrea International SA	PASS LP SPINAL SYSTEM	2015-01-09
K160980	Spineology, Inc.	Threshold Pedicular Fixation System, Palisade Pedicular Fixation System	2016-05-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009554293. Last updated year: 2026. Please use registration number 3009554293 when referencing this establishment in official correspondence.