BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Synthes Navigable Pedicle Preperation Instruments (03.632.230, 03.632.422)

    Reg #: 3007925235 · FEI: 3007925235 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ARCH - Blandon
    Registration Number
    3007925235
    FEI Number
    3007925235
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    321 June Ave
    City
    Blandon
    State
    PA
    ZIP
    19510
    Country
    US

    Regulatory Submissions

    510(k) Number
    K122211

    Owner / Operator

    Firm Name
    ARCH - Blandon
    Operator Number
    10042720
    Address
    321 June Ave
    City
    Blandon
    State
    PA
    Postal Code
    19510
    Country
    US
    Correspondent
    Megan Reinert

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    Synthes Navigable Pedicle Preperation Instruments (03.632.230, 03.632.422)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)