BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Surgic AP(120V)

    Reg #: 1422375 · FEI: 1000139790 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    26
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NSK AMERICA CORP.
    Registration Number
    1422375
    FEI Number
    1000139790
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1800 Global Parkway
    City
    Hoffman Est
    State
    IL
    ZIP
    60192
    Country
    US

    Regulatory Submissions

    510(k) Number
    K020327

    Owner / Operator

    Firm Name
    NAKANISHI INC.
    Operator Number
    8030216
    Address
    1800 Global Pkwy
    City
    Hoffman Est
    State
    IL
    Postal Code
    60192
    Country
    US
    Correspondent
    Satoru Ikeda

    Products

    Device Name Product Code
    Controller, Foot, Handpiece And Cord EBW

    Proprietary Names

    Surgic AP(120V) SG50MS Motor Surgic XTSTT230ERMS Surgic XT Plus 120V N-OPT SG50LED Surgic XT P12 Surgic XT12 w/o HP Surgic AP S 230 Surgic AP S 120 Surgic IV Implant Control Unit SG50M Surgic XTSTT120ERMS SurgicXTSTT120ERMS SGL50M Motor Surgic XT Plus 120V OPT SG50MS Surgic XTSTT120MS w/o HP Surgic XT Plus 230V OPT SGL50M NE179 SurgicXTSTT120MS without Handpiece Surgic XT Plus 120V LED Surgic XTS120 Surgic XT P23 SurgicXT Plus W/O(120V) Surgic XT Plus 230V N-OPT

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198