BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Translace Fixation Cerclage Sublaminar

    Reg #: 3013378907 · FEI: 3013378907 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SANAVITA MEDICAL, LLC
    Registration Number
    3013378907
    FEI Number
    3013378907
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    551 E Church Ave
    City
    Telford
    State
    PA
    ZIP
    18969
    Country
    US

    Regulatory Submissions

    510(k) Number
    K163181

    Owner / Operator

    Firm Name
    SanaVita Medical, LLC
    Operator Number
    10052937
    Address
    195 O'Neill Drive
    City
    Quakertown
    State
    PA
    Postal Code
    18951
    Country
    US
    Correspondent
    Kitu Patel

    Products

    Device Name Product Code
    Bone Fixation Cerclage, Sublaminar OWI

    Proprietary Names

    Translace Fixation Cerclage Sublaminar

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)