BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PRIMAL OK INTERSPINOUS FUSION SYSTEM

    Reg #: 3006172536 · FEI: 3006172536 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Wenzel Spine
    Registration Number
    3006172536
    FEI Number
    3006172536
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2535 Brockton Dr Ste 450
    City
    Austin
    State
    TX
    ZIP
    78758
    Country
    US

    Regulatory Submissions

    510(k) Number
    K100354

    Owner / Operator

    Firm Name
    Wenzel Spine, Inc.
    Operator Number
    10030760
    Address
    2535 Brockton Dr, Suite 450
    City
    Austin
    State
    TX
    Postal Code
    78758
    Country
    US
    Correspondent
    Erik Emstad

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Interlaminal KWP

    Proprietary Names

    PRIMAL OK INTERSPINOUS FUSION SYSTEM

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility