BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    CG BIO CO., LTD.

    Reg #: 3017036472 · FEI: 3017036472 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    120
    Establishment Types
    2
    Classifications
    12

    Registration Details

    Registration Name
    CG BIO CO., LTD.
    Registration Number
    3017036472
    FEI Number
    3017036472
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Part of C-dong, Part of D-dong, 29, Jeyakdanji-ro, Hyangnam-eup, Manse-gu
    City
    Hwaseong-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K222229

    Owner / Operator

    Firm Name
    CG Bio Co., Ltd.
    Operator Number
    10040923
    Address
    2F, CG Building, 1 Sangwon 12-gil, Seongdong-gu
    City
    Seoul
    State
    KR-11
    Postal Code
    04791
    Country
    KR
    Correspondent
    Suwon Lee

    US Agent

    Business Name
    Fortrea Inc.
    Contact Name
    Cori Ragan
    Address
    8 Moore Dr
    City
    Durham
    State
    NC
    ZIP
    27713
    Country
    US
    Email
    [email protected]
    Phone
    651 2736916

    Products

    Device Name Product Code
    Elastomer, Silicone, For Scar Management MDA
    Thoracolumbosacral Pedicle Screw System NKB
    Orthopedic Manual Surgical Instrument LXH
    Bandage, Liquid, Skin Protectant NEC
    Dressing, Wound, Occlusive NAD
    Dressing, Wound, Hydrophilic NAC
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Bone Grafting Material, Synthetic LYC
    Negative Pressure Wound Therapy Powered Suction Pump OMP
    Bone Marrow Biopsy Tray PXO
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC

    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 Centrifuge (MD416) + Concentration Kit (CGBMC) MD416, CGBMC Kit

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility