BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BioDynamik

    Reg #: 3030966822 · FEI: 3030966822 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    7

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    Registration Details

    Registration Name
    BioDynamik
    Registration Number
    3030966822
    FEI Number
    3030966822
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    11 Orchard Ste 107
    City
    Lake Forest
    State
    CA
    ZIP
    92630
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241357

    Owner / Operator

    Firm Name
    BioDynamik, Inc
    Operator Number
    10091366
    Address
    11 Orchard Rd, Suite 107
    City
    Lake Forest
    State
    CA
    Postal Code
    92630
    Country
    US
    Correspondent
    Johnny Chen

    Products

    Device Name Product Code
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Pin, Fixation, Threaded JDW
    Template HWT
    Screwdriver HXX
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Orthopedic Manual Surgical Instrument LXH
    Elevator HTE

    Proprietary Names

    PERIOSTEAL ELEVATOR LOCKING BOLT

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility