BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PELETON SURGICAL

    Reg #: 3019932374 · FEI: 3019932374 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    PELETON SURGICAL
    Registration Number
    3019932374
    FEI Number
    3019932374
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1435 North Hayden Road, Suite 100
    City
    Scottsdale
    State
    AZ
    ZIP
    85257
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240071

    Owner / Operator

    Firm Name
    Peleton Surgical
    Operator Number
    10082475
    Address
    1435 North Hayden Road, Suite 100
    City
    Scottsdale
    State
    AZ
    Postal Code
    85257
    Country
    US
    Correspondent
    Andy J Bala

    Products

    Device Name Product Code
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Battery-Powered Instruments Charged Through Sterile Barriers SAM

    Proprietary Names

    Peleton Universal Single Use Power System and Attachments

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility