BEUDAMED
    FDA Registration Active 🇧🇷 Brazil

    Mini-OSTEO Pedicle Fixation System

    Reg #: 3023138345 · FEI: 3023138345 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    OSTEOMED IMPLANTES
    Registration Number
    3023138345
    FEI Number
    3023138345
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rod Washington Luis km 172, pista sul - cond. ind.conpark
    City
    Rio Claro Sao Paulo
    Country
    BR

    Regulatory Submissions

    510(k) Number
    K231443

    Owner / Operator

    Firm Name
    Osteomed Implantes
    Operator Number
    10085391
    Address
    Rod Washington Luis km 172, pista sul - cond. ind.conpark
    City
    Rio Claro
    State
    Sao Paulo
    Postal Code
    13500970
    Country
    BR
    Correspondent
    Fernando Argenton Neto

    US Agent

    Business Name
    Passarini Regulatory Affairs of America LLC
    Contact Name
    Lucas Rodrigues
    Address
    10185 Henbury St
    City
    Orlando
    State
    FL
    ZIP
    32832
    Country
    US
    Email
    [email protected]
    Phone
    786 8496760

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Interlaminal KWP
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    Mini-OSTEO Pedicle Fixation System

    Establishment Types

    Manufacture Medical Device