BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    4CIS® Archon Cage 45x15xH9x6d

    Reg #: 3004941535 · FEI: 3004941535 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    64
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ALPHANOX CO., LTD.
    Registration Number
    3004941535
    FEI Number
    3004941535
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    154, Seotan-ro, Seotan-myeon
    City
    PYEONGTAEK Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K190563

    Owner / Operator

    Firm Name
    ALPHANOX CO., LTD
    Operator Number
    9036105
    Address
    154, Seotan-ro, Seotan-myeon, --
    City
    PYEONGTAEK
    State
    Gyeonggi
    Postal Code
    17704
    Country
    KR

    US Agent

    Business Name
    SOLCO BIOMEDICAL CORPORATION
    Contact Name
    Cindy Lee
    Address
    4100 Midway Rd Ste 1130
    City
    Carrollton
    State
    TX
    ZIP
    75007
    Country
    US
    Email
    [email protected]
    Phone
    972 2472486

    Products

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

    Proprietary Names

    4CIS® Archon Cage 45x15xH9x6d 4CIS® Archon Cage 50x17xH11x6d 4CIS® Archon Cage 40x17xH11x6d 4CIS® Archon Cage 50x15xH13x6d 4CIS® Archon Cage 50x15xH15x12d 4CIS® Archon Cage 50x17xH13x6d 4CIS® Archon Cage 40x17xH13x6d 4CIS® Archon Cage 50x15xH15x6d 4CIS® Archon Cage 40x15xH15x6d 4CIS® Archon Cage 50x15xH11x12d 4CIS® Archon Cage 40x15xH11x12d 4CIS® Archon Cage 45x17xH13x6d 4CIS® Archon Cage 45x17xH8x6d 4CIS® Archon Cage 40x17xH15x6d 4CIS® Archon Cage 50x17xH9x6d 4CIS® Archon Cage 45x15xH11x12d 4CIS® Archon Cage 45x15xH11x6d 4CIS® Archon Cage 45x15xH15x6d 4CIS Pebble Beach PEEK PLIF Cage; 4CIS PEEK PLIF Cage; 4CIS Torrey Pines PEEK TLIF Cage 4CIS Augusta PEEK ALIF Cage; 4CIS Dunes PEEK DLIF Cage; 4CIS® Dunes PEEK DLIF Cage 12degree, 45x18x8mm 4CIS® Augusta Trial 323x36x26x18, 20degree 4CIS® Dunes PEEK DLIF Cage 12degree, 45x18x10mm 4CIS® Dunes PEEK DLIF Cage 12degree, 55x18x8mm 4CIS® Augusta Trial 323x36x26x20, 20degree 4CIS® Dunes PEEK DLIF Cage 12degree, 40x18x10mm 4CIS® Dunes PEEK DLIF Cage 12degree, 55x18x14mm 4CIS® Dunes PEEK DLIF Cage 12degree, 40x18x12mm 4CIS® Dunes PEEK DLIF Cage 12degree, 45x18x12mm 4CIS® Augusta Trial 323x36x26x12, 20degree 4CIS® Augusta Trial 323x36x26x14, 20degree 4CIS® Augusta Trial 323x36x26x16, 6degree 4CIS® Dunes PEEK DLIF Cage 12degree, 45x18x14mm 4CIS® Dunes PEEK DLIF Cage 12degree, 55x18x12mm 4CIS® Archon Cage 45x17xH15x6d 4CIS® Archon Cage 50x15xH9x6d 4CIS® Archon Cage 40x15xH9x6d 4CIS® Archon Cage 40x15xH13x6d 4CIS® Archon Cage 45x15xH15x12d 4CIS® Dunes PEEK DLIF Cage 12degree, 50x18x12mm 4CIS® Archon Cage 50x17xH15x6d 4CIS® Augusta Trial 323x36x26x12, 6degree 4CIS® Archon Cage 40x15xH15x12d 4CIS® Dunes PEEK DLIF Cage 12degree, 50x18x14mm 4CIS® Archon Cage 50x15xH11x6d 4CIS® Archon Cage 45x17xH9x6d 4CIS® Archon Cage 45x17xH11x6d 4CIS® Dunes PEEK DLIF Cage 12degree, 50x18x8mm 4CIS® Dunes PEEK DLIF Cage 12degree, 40x18x8mm 4CIS® Dunes PEEK DLIF Cage 12degree, 50x18x10mm 4CIS® Dunes PEEK DLIF Cage 12degree, 40x18x14mm 4CIS® Dunes PEEK DLIF Cage 12degree, 55x18x10mm 4CIS® Augusta Trial 323x36x26x20, 6degree 4CIS® Augusta Trial 323x36x26x10, 6degree 4CIS® Augusta Trial 323x36x26x16, 20degree 4CIS® Augusta Trial 323x36x26x14, 6degree 4CIS® Augusta Trial 323x36x26x18, 6degree 4CIS® Archon Cage 45x15xH13x6d 4CIS® Archon Cage 40x15xH11x6d 4CIS® Archon Cage 45x15xH13x12d 4CIS® Archon Cage 40x17xH9x6d 4CIS® Archon Cage 50x15xH13x12d 4CIS® Archon Cage 40x15xH13x12d

    Establishment Types

    Manufacture Medical Device