BEUDAMED
    FDA Registration Active 🇮🇳 India

    RAPHAEL™ TAP, 1/4" SQUARE QC, D6.5, CORTICAL

    Reg #: 3016443334 · FEI: 3016443334 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    3

    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
    K132365

    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
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH

    Proprietary Names

    RAPHAEL™ TAP, 1/4" SQUARE QC, D6.5, CORTICAL PEDICLE SCREW DISTRACTOR RAPHAEL™ Tap, 1/4" Square Male QC, D4.5 Rod Reducing Tower, 5.5 Rod, Long T-Handle, Tower Sleeve Rod Reducer Intervertebral fusion device with bone graft, lumbar Knob, Tower Sleeve Rod Reducer RAPHAEL™ Tap, 1/4" Square Male QC, D5.5 Hex Driver, 1/4" Square QC, 4 Ratcheting Raphael Pedicle Screw System Driver Shaft, Tower Sleeve Rod Reducer Rod Reducer Tower, 5.5mm, Short Awl, Cannulated Hex Driver, 1/4" Square QC, Self-Retention, 5mm HEX DRIVER, 1/4" SQ QC, SELF-RETENTION HEX DRIVER 0.25"SQUARE QC RATCHETING

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)