BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    BK MEDITECH CO., LTD.

    Reg #: 3004176895 · FEI: 3004176895 · Expires 2026
    View on FDA
    Products
    26
    Proprietary Names
    131
    Establishment Types
    2
    Classifications
    26

    Registration Details

    Registration Name
    BK MEDITECH CO., LTD.
    Registration Number
    3004176895
    FEI Number
    3004176895
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    58, Eunhaengnamu-ro, Yanggam-myeon
    City
    Hwaseong-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K120464

    Owner / Operator

    Firm Name
    BK MEDITECH CO., LTD.
    Operator Number
    9059102
    Address
    58, Eunhaengnamu-ro, Yanggam-myeon, --
    City
    Hwaseong-si
    State
    Gyeonggi
    Postal Code
    18633
    Country
    KR
    Correspondent
    BYOUNGJUN - PARK

    US Agent

    Business Name
    Paladin Medical, Inc.
    Contact Name
    Elaine Duncan
    Address
    415 Valley View Trail
    City
    Houlton
    State
    WI
    ZIP
    54082
    Country
    US
    Email
    [email protected]
    Phone
    715 5496035

    Products

    Device Name Product Code
    Rasp HTR
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    Tray, Surgical, Instrument FSM
    Caliper KTZ
    Thoracolumbosacral Pedicle Screw System NKB
    Cutter, Surgical FZT
    Probe HXB
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Pusher, Socket HXO
    Wrench HXC
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Screwdriver HXX
    Orthopedic Manual Surgical Instrument LXH
    Awl HWJ
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Tap, Bone HWX
    Pin, Fixation, Threaded JDW
    Blade, Scalpel GES
    Instrument, Compression HWN
    Curette HTF
    Impactor HWA
    Bender HXW
    Holder, Needle; Orthopedic HXK
    Retractor GAD

    Proprietary Names

    SHAVER RASP INNESIS PEEK CAGE MEGA SPINE SYSTEM SURGICAL INSTRUMENT TRAY CALIPERS MEGA PLUS SPINE SYSTEM LONG-ARM BREAKER TAB BREAKER STRAIGHT PROBE BENT PROBE STRAIGHT PROBE(LENKE) BENT PROBE(LENKE) CANNULATED PROBE Dyna-EXTOR II External Fixation System MEGA5.5 SPINE SYSTEM ROD INTRODUCER ROD PUSHER ROD ROCKER FINAL WRENCH(4.5MM) PICK-UP WRENCH(5MM) 3.5MM FINAL TIGHTENER FINAL WRENCH(5MM) WRENCH 3(3MM HEX) PICK-UP WRENCH(4.5MM) DOUBLE STARTER FINAL WRENCH(BT20) REDUCER T-WRENCH DUAL LOCKING WRENCH PICK-UP WRENCH FINAL WRENCH(BT30) MIS Final Wrench(BT20) MIS Dual Locking Wrench MIS Final Wrench(BT30) INNESIS PEEK CERVICAL CAGE MULTI-AXIAL SCREW DRIVER ALIGNMENT DRIVER MONO SCREW DRIVER LONG-ARM SCREW DRIVER LONG-ARM MULTI-AXIAL SCREW DRIVER DISTRACTION SCREW DRIVER TURNBUCKLE DRIVER-FIXED SCREW DRIVER INTERMEDIATE SCREW DRIVER ILIAC SCREW DRIVER CANNULATED ADJUST DRIVER MIS SCREW DRIVER REDUCTION INTRODUCER GUIDE PIN(L) ROD GRIPPER GUIDE PIN(R) ANTI TORQUE DRIVER I-TYPE RATCHET HANDLE T-TYPE RATCHET HANDLE PERSUADER SQ-ADAPTER HANDLE TESTER CAGE SUPPORT GRAFT CASE BONE FILLER TRIAL DISTRACTION SCREW EXTRACTOR ANTI TORQUE BALL POINT TESTER LEFT MARKER RIGHT MARKER 4 SIDED I-RATCHET HANDLE REDUCER MINI T-RATCHET HANDLE LARGE T-TORQUE HANDLE DISTRACTOR SPINNER REDUCER STICK DEROTATOR HANDLE ROTATION HANDLE ROTATION TUBE SPANNER DEROTATION CLIP CLIP WRENCH RELEASE T-BLOCK ONE-STEP MIS DRIVER SC REDUCER TAB ALIGNMENT SMALL DILATOR FASCIA CUTTER LARGE DILATOR MEDIUM DILATOR ANTI TORQUE SLEEVE LINKAGE HANDLE DEROTATOR LINKAGE WIRE HOLDER ROD HOLDER INTER LINK CROSS BAR T-TORQUE HANDLE INJECTOR WRENCH INNER ANTI TORQUE GUIDE WIRE LONG ROD INSERTER OUTER RING DYE INJECTOR INTER LINK ANTI TORQUE HANDLE LONG TAB PROTECTOR AWL CANNULATED AWL Prase-C Anterior Cervical Plate System TAP CANNULATED TAP PIN SCREW HAKI Knife DVX5.5 SPINE SYSTEM COMPRESSOR BALL CURETTE GRAFT IMPACTOR STRAIGHT IMPACTER FINAL IMPACTOR IMPACTOR GRAFT INSERTER INSERTER CURVED IMPACTER ROD BENDER FRENCH ROD BENDER MEGA PLUS MIS SPINE SYSTEM DVX SPINE SYSTEM ROD FORCEPS POWER ROD FORCEPS INNESIS PEEK TL CAGE DURA RETRACTOR ROOT RETRACTOR

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)