BEUDAMED
    FDA Registration Active 🇮🇳 India

    SHORT BLUNT DISTRACTOR, H10mm, 1/4" QC

    Reg #: 3016443334 · FEI: 3016443334 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    50
    Establishment Types
    1
    Classifications
    2

    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
    K160646

    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
    Spinal Vertebral Body Replacement Device MQP
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX

    Proprietary Names

    SHORT BLUNT DISTRACTOR, H10mm, 1/4" QC RODIN Trial, 6 degree , W27xL21, H12mm SHORT BLUNT DISTRACTOR, H8mm, 1/4" QC Remover Tamp, H9~16 RODIN Trial, 6 degree , W27xL21, H9mm Rodin Inserter RODIN Disc Shaver, 9mm SHORT BLUNT DISTRACTOR, H9mm, 1/4" QC GRAFT DELIVERY DEVICE Implant Inserter, Lever RODIN Preliminary Annulotomy Cutter Expansion Driver, 1/4" QC, Lever Impactor COLLET TIGHTENER CEZANNE-MONDRIAN, TL CURVED ARTICULATING INSERTER Intervertebral fusion device with bone graft, lumbar RODIN Trial, 6 degree , W27xL21, H14mm Remover Collet Initial Paddle Distractor RODIN Disc Shaver, 13mm Plunger, Graft Delivery Device RODIN Box Cutter, 10 mm RODIN Disc Shaver, 7mm RODIN Trial, 6 degree, W30xL25, H10mm RODIN Disc Shaver, 12mm RODIN Disc Shaver, 8mm RODIN Disc Shaver, 10mm RODIN Trial, 6 degree W27xL21, H10mm RODIN Disc Shaver, 14mm Freehand Tamp T-HANDLE, QC, SQ, M5 RODIN Box Cutter, 8 mm RODIN Trial, 6 degree, W30xL25, H14mm Inserter Collet RODIN Trial, 6 degree, W30xL25, H8mm RODIN Disc Shaver, 11mm RODIN Box Cutter, 9 mm Expansion Tamp RODIN Trial, 6 degree , W27xL21, H11mm Freehand Tamp, Bent RODIN Trial, 6 degree, W30xL25, H13mm RODIN Trial, 6 degree , W27xL21, H13mm RODIN Trial, 6 degree, W30xL25, H12mm Remover Tamp, H6~12 Expansion Driver, 1/4" QC, Impactor Lever RODIN Trial, 6 degree, W30xL25, H11mm Expansion Driver Box Cutter Strike Plate RODIN Trial, 6 degree, W30xL25, H9mm Rodin Implant Inserter

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)