BEUDAMED
    FDA Registration Active 🇮🇳 India

    Intervertebral fusion device with bone graft, Cervical

    Reg #: 3016443334 · FEI: 3016443334 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
    Registration Number
    3016443334
    FEI Number
    3016443334
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SURVEY NO-1540, BESIDE TORRENT PHARMA,, AHMEDABD-MEHSANA HIGHWAY, VILLAGE-RAJPUR
    City
    KADI Gujarat
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K172212

    Owner / Operator

    Firm Name
    SOLCO BIOMEDICAL CO
    Operator Number
    10077960
    Address
    5 & 6, 3rd Floor, B. Jadav Chambers,, Ashram Road
    City
    AHMEDABAD
    State
    Gujarat
    Postal Code
    380009
    Country
    IN

    US Agent

    Business Name
    Carrasco
    Contact Name
    Mateo Carrasco
    Address
    1815 Barker drive
    City
    Winter Park
    State
    FL
    ZIP
    32789
    Country
    US
    Email
    [email protected]
    Phone
    407 2849480

    Products

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

    Proprietary Names

    Intervertebral fusion device with bone graft, Cervical ACIF TRIAL- W 14x L12, 6 DEG, H9/ H10 ACIF TRIAL- W17 x L14, 6 DEG, H7/H8 ACIF TRIAL- W 14x L12, 6 DEG, H5/ H MATISSE™ ACIF Cage, Titanium-PEEK - W17 x L14, 6Deg., H6mm MATISSE™ ACIF Cage, Titanium-PEEK - W17 x L14, 6Deg., H10mm MATISSE™ ACIF Cage, Titanium-PEEK - W17 x L14, 6Deg., H8mm MATISSE™ ACIF Cage, Titanium-PEEK - W14 x L12, 6Deg., H8mm ACIF TRIAL- W 14x L12, 6 DEG, H7/ H8 MATISSE™ ACIF Cage, Titanium-PEEK - W14 x L12, 6Deg., H9mm MATISSE™ ACIF Cage, Titanium-PEEK - W17 x L14, 6Deg., H7mm MATISSE™ ACIF Cage, Titanium-PEEK - W14 x L12, 6Deg., H7mm MATISSE™ ACIF Cage, Titanium-PEEK - W17 x L14, 6Deg., H6mm - ACIF TRIAL- W17 x L14, 6 DEG, H5/H6 ACIF TRIAL- W17 x L14, 6 DEG, H9/H10 MATISSE™ ACIF Cage, Titanium-PEEK - W17 x L14, 6Deg., H9mm MATISSE™ ACIF Cage, Titanium-PEEK - W14 x L12, 6Deg., H6mm MATISSE™ ACIF Cage, Titanium-PEEK - W14 x L12, 6Deg., H10mm

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)