Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017036472

FEI Number

3017036472

Entity Name

CG BIO CO., LTD.

City/State/Country

Hwaseong-si Gyeonggi, KR

Establishment Address

Part of C-dong, Part of D-dong, 29, Jeyakdanji-ro, Hyangnam-eup, Manse-gu, Hwaseong-si Gyeonggi 18608, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CG Bio Co., Ltd. (Owner Number: 10040923)

Owner / Operator Contact Address

2F, CG Building, 1 Sangwon 12-gil, Seongdong-gu, Seoul, KR-11 04791, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

. Advanced LumFix Spinal Fixation System Threaded Spindle Extender Remover DB Probe, Straight, B type Double Lead Tapper, 4.5 BONE GRAFT PUSHER 70-75 Cannula Ted Tapper Locking mono screw driver, B type Rod Gripper 6 60-65 Cannula Ted Tapper Rod bender, D type Slip on Extender Ball Tip Driver Instrument tray 5.5, C type Double Lead Tapper, 8.5 Guide inserter IMPACTOR-1 L Screw Driver Double Lead Tapper, 4-4.5 LATERAL QUICK HANDLE Rod Tray, D type Double Lead Tapper, 6.5 Rod Rotator Dilator Screw head Adjuster, B type Poly screw driver power Rigid Rod Inserter Palm handle Derotator ,Sharp ,D Type Poly screw driver Short Set Screw Starter Counter Torque, D Type Reduction Poly screw driver Short Cannula with Handle Spindle Nut Extender Driver Reduction Cutter B type BONE GRAFT MIXER-RING Reduction mono screw driver, B type 13 Nm Torque wrench Sounder, Curve, Btype T-handle, B type DB probe M type, straight Double Lead Tapper, 5-5.5 Rod fork 5.5 Novosis putty disposable device ?1.5 Guide Wire Set screw starter, D type T-Ratchet Handle Sounder, Straight, B type CANNULA FOR CAGE L Locking poly screw driver, B type 5.5 Nm Torque wrench Table rod cutter I-Ratchet Handle Double Lead Tapper, 8-8.5 BONE GRAFT CANNULA (IN) Rod holder Rod fork 6 Double Lead Tapper, 7-7.5 Double Lead Tapper, 5.5 Rod Reducer Counter torque, B type Reduction Handle Palm-Ratchet Handle In-situ bender 6, Left Segmental Derotator IMPACTOR-1 S Compressor, B type DB probe M type, Curved Double Lead Tapper, 6-6.5 Screw Extender Implant tray 5.5 Double Lead Tapper, 7.5 MDR tightener CANNULA FOR CAGE S Reduction poly screw driver, B type Screw head adjuster Pusher Rod Checker DB Probe, Curve, B type FUNNEL FOR BONE CHIP COLONNADE CONTAINER Set screw driver L Counter Torque Compressor Fulcrum In-situ bender 6, right MDR instrument Tray SURGICAL INSTRUMENT CONTAINER Minilif Rod Inserter MIS Compressor Coronal Bender 6, Left Awl C Persuader 5.5 Derotator, Sharp, C type 50-55 Cannula Ted Tapper Coronal Bender 6, right Pusher 6 Adjustment screw driver Torque Wrench Rod bender, C type Distractor, B type Locking Reduction Mono Screw driver Ratcheting Handle . EASYTACT EZ Derm Easyderm plus Easyfoam Silicone Border Easyfoam Silicone Heel Easyderm thin Easyfoam Easyderm plus thin Easyderm foam LumFix Spinal Fixation System Bongros COLONNADE Posterior Screw Fixation System KulaVAC .

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2016-02-11
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-06-07
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2019-11-22
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2012-06-03
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2024-02-02
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2012-06-07
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-11-14
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-11-14
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2023-02-16
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-05-11
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2014-04-18
PXO	Bone Marrow Biopsy Tray	General, Plastic Surgery	Class 1	878.4800	2018-09-06

Official Correspondent

Suwon Lee

US Agent Details

Cori Ragan Business: Fortrea Inc. Email: Cori.Ragan@fortrea.com Phone: (651) 2736916

Related Public Records

Same Entity

CG Bio Co., Ltd.

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

View Entity Profile →

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 3017036472. Last updated year: 2026. Please use registration number 3017036472 when referencing this establishment in official correspondence.