BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Trial Anatomic dual 12*14*11-12mm

    Reg #: 3021945817 · FEI: 3021945817 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    93
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HO MEDI Co., Ltd
    Registration Number
    3021945817
    FEI Number
    3021945817
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ra, je1dong, 307-1 Chilbongsan-Ro
    City
    Yangju Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K212792

    Owner / Operator

    Firm Name
    HO MEDI
    Operator Number
    10092686
    Address
    RA, JE1Dong, 307-1, Chilbongsan-ro
    City
    Yangju-si
    State
    Gyeonggi
    Postal Code
    11448
    Country
    KR
    Correspondent
    MINSU KIM

    US Agent

    Business Name
    MEDYNUS INC
    Contact Name
    David Daewon
    Address
    18 Technology Dr Ste 109
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 9320847

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX

    Proprietary Names

    Trial Anatomic dual 12*14*11-12mm UV Retractor(80mm) (END-WT080) Indian Knife (END-DK001) UV Retractor(40mm) (END-WT040) Root Retractor (END-RR001) Trial Lordotic 14*16*7mm (CCN-00011) Trial Anatomic 14*16*6mm (CCN-00026) Serial Dilator 2 (END-SD002) Serial Dilator 1 (END-SD001) Rotator Kerrison Handle (END-RKH01) Trial Lordotic dual 14*16*11-12mm Trial Anatomic 12*14*6mm (CCN-00018) Trial Lordotic dual 14*16*7-8mm Micro Pituitary(Up) (END-MPU2M) UV Retractor(70mm) (END-WT070) Curved Kerrison 3mm (END-CK03M) Rotator Kerrison Head(2mm) (END-RKSH2) Trial Anatomic dual 12*14*5-6mm Cervical Cage Anatomic Implant Caddy (CNR-00003) Bone Curette(5mm) (END-CU03M) Trial Anatomic 12*14*9mm (CCN-00021) Bone Curette(Reverse 3mm) (END-CUR3M) Trial Lordotic 12*14*11mm (CCN-00007) Freer (END-PF001) Trial Anatomic 12*14*10mm (CCN-00022) Trial Anatomic dual 14*16*7-8mm Mallet (END-MA001) Trial Lordotic 14*16*5mm (CCN-00009) Hockey Chisel(Left 5mm) (END-OTL5M) Trial Lordotic 12*14*9mm (CCN-00005) Trial Anatomic dual 14*16*5-6mm Trial Lordotic 14*16*6mm (CCN-00010) Trial Anatomic 12*14*8mm (CCN-00020) Trial Anatomic dual 12*14*9-10mm Cervical Cage impactor (CCN-00052) Rotator Kerrison Head(3mm) (END-RKSH3) BESS Tray with Lid (END-TR001) Rotator Kerrison Curved Head(2mm) (END-RKCH2) Cervical Cage holder (CCN-00051) Micro Pituitary(Straight) (END-MPS2M) CERVICAL CAGE IMPLANTS CONTAINER (CCT-00001, AICN-1005-0001, and others) Trial Anatomic 14*16*7mm (CCN-00027) Trial Lordotic 12*14*6mm (CCN-00002) Trial Anatomic dual 14*16*11-12mm Cervical Cage bone impactor (CCN-00053) Trial Lordotic dual 12*14*9-10mm Pedicle Chisel(5mm) (END-OTP5M) Curved Kerrison 2mm (END-CK02M) Hockey Chisel(Right 5mm) (END-OTR5M) Trial Lordotic 12*14*10mm (CCN-00006) Trial Anatomic 12*14*12mm (CCN-00024) Trial Anatomic 14*16*11mm (CCN-00031 Trial Anatomic 14*16*5mm (CCN-00025) Cervical Cage Lordotic Implant Caddy (CNR-00002) Trial Anatomic 14*16*12mm (CCN-00032) Trial Lordotic 14*16*10mm (CCN-00014) Trial Anatomic 12*14*11mm (CCN-00023) Bone Curette(3mm) (END-CU05M) Rotator Kerrison Curved Head(3mm) (END-RKCH3) Cervical Cage Container (CCT-00001) Trial Lordotic dual 14*16*9-10mm Trial Lordotic 14*16*11mm (CCN-00015) Pixie (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage UV Retractor(60mm) (END-WT060) Dilator (END-MD001) UV Retractor(100mm) (END-WT100) UV Retractor(50mm) (END-WT050) UV Retractor(90mm) (END-WT090) Trial Lordotic 14*16*9mm (CCN-00013) Trial Lordotic 14*16*12mm (CCN-00016) Trial Lordotic dual 12*14*5-6mm Trial Lordotic 14*16*8mm (CCN-00012) Spinal Cord Retractor Straight (END-SCRS1) Serial Dilator 4 (END-SD004) Chisel(Stright 5mm) (END-OTS5M) Trial Anatomic 14*16*10mm (CCN-00030) Trial Anatomic 12*14*5mm (CCN-00017) Trial Anatomic 14*16*9mm (CCN-00029) Trial Anatomic 14*16*8mm (CCN-00028) Trial Lordotic dual 12*14*7-8mm Trial Lordotic dual 14*16*5-6mm Boomerang Curette(3mm) (END-CUB3M) Trial Anatomic dual 14*16*9-10mm Verana (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage and Instrument sets including its containers Trial Lordotic 12*14*7mm (CCN-00003) Serial Dilator 3 (END-SD003) Trial Lordotic dual 12*14*11-12mm Spinal Cord Retractor Curved (END-SCRC1) Trial Lordotic 12*14*5mm (CCN-00001) Trial Lordotic 12*14*12mm (CCN-00008) Bone Curette(5mm) (END-CU06M) Trial Lordotic 12*14*8mm (CCN-00004) Trial Anatomic dual 12*14*7-8mm

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)