BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    CORENTEC CO., LTD.

    Reg #: 3009106092 · FEI: 3009106092 · Expires 2026
    View on FDA
    Products
    55
    Proprietary Names
    23
    Establishment Types
    2
    Classifications
    55

    Registration Details

    Registration Name
    CORENTEC CO., LTD.
    Registration Number
    3009106092
    FEI Number
    3009106092
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    12,Yeongsanhong 1-gil, Ipjang-Myeon,, Seobuk Gu,
    City
    Cheonan Si, Chungnam
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K122099

    Owner / Operator

    Firm Name
    Corentec Co., Ltd.
    Operator Number
    10037247
    Address
    12, Yeongsanhong 1-gil, Ipjang-Myeon,, Seobuk Gu,
    City
    Cheonan Si,
    State
    Chungnam
    Postal Code
    31056
    Country
    KR

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Wrench HXC
    Bit, Drill HTW
    Instrument, Cutting, Orthopedic HTZ
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Stripper, Surgical HRT
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Instrument, Compression HWN
    Pusher, Socket HXO
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Thoracolumbosacral Pedicle Screw System NKB
    Instrument, Bending Or Contouring HXP
    Awl HWJ
    Osteotome HWM
    Driver, Prosthesis HWR
    Broach HTQ
    Knee Arthroplasty Implantation System OOG
    Guide, Surgical, Instrument FZX
    Protractor HTH
    Screwdriver HXX
    Probe HXB
    Tape, Measuring, Rulers And Calipers FTY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Tap, Bone HWX
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Template HWT
    Orthopedic Manual Surgical Instrument LXH
    Spatula, Orthopedic HXR
    Extractor HWB
    Impactor HWA
    Bender HXW
    Caliper KTZ
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Reamer HTO
    Corkscrew HWI
    Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ
    Accessories, Arthroscopic NBH
    Rongeur HTX
    Accessories, Fixation, Spinal Intervertebral Body LYQ
    Tamp HXG
    Gauge, Depth HTJ
    Tray, Surgical, Instrument FSM
    Positioner, Socket KIL
    Crimper, Pin HXQ
    Forceps HTD
    Holder, Needle; Orthopedic HXK
    Rasp HTR
    Chisel, Surgical, Manual FZO

    Proprietary Names

    BENCOX LOSPA EXULT Knee Replacement System EXULT LOSPA IS LOSPA IS Spinal Fixation System Rhino Percutaneous Pedicle Screw LOSPA IS Thoracolumbar Pedicle Screw LOSPA Knee System EXULT Femoral Component Trials BENCOX Mirabo Z Cup Cortinium EXULT TKR Surgical Instrumentation Corentec Orthopedic Surgical Instrumentation LOSPA Modular TKR Surgical Instrumentation BENCOX THR SYSTEM Instruments BENCOX THR SYSTEM Bencox BENCOX Delta Option Head System BENCOX Mirabo Cup BENCOX Mirabo PE Liner LOSPA TKR SYSTEM INSTRUMENTATION LOSPA Tibial Insert Trial BENCOX MIRABO

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device