BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PD-DA-A

    Reg #: 1422375 · FEI: 1000139790 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    105
    Establishment Types
    1
    Classifications
    4

    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
    K132264

    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
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Motor, Drill, Electric HBC
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE

    Proprietary Names

    PD-DA-A P200-RA330 P200-3GAM PD-2AES PD-2ADM P200-2AMS P200-3MC P200-1A155-C P200-CRD-L PD-DA-J4 P200-SMH-HS PD-RA-A P200-SAG-S-HS PD-1A155-10 P200-2SD PD-CRD-M NSK Sterile Burs/Drills PD-DA-W P200-REC-S PD-CRA PD-1A175-10 PD-RA-T NSK Sterile Rasps/Files PD-SA-R P200-1A175 PD-1A135 PD-RA330 P200-2SES P200-RA330-L P200-BMH-HS P200-CU-120 P200-RCRD-P P200-CRD-M PD-RA-H PD-2SES PD-2SDM P200-RCRD-L PD-2AD PD-3GAL P200-2SMS PD-1A155 P200-HMH PD-1A95 PD-DA-K PD-CA-16 P200-BMH P200-2AL P200-REC NSK Sterile Blades P200-CRA P200-OSC-S PD-3GAM PD-3GAS P200-1A175-C P200-HMH-HS P200-SMH P200-CA-4 P200-2AES P200-CRD-P P200-2SM P200-RA155 P200-SMH-S P200-RCRD-M PD-2SM NSK Sterile Burs/Disk P200-SAG-S P200-OSC PD-RA95 PD-CRD-L PD-2SL P200-2AM P200-1A155-U PD-2SD PD-2AL P200-WPD P200-CU-230 PD-CA-256 P200-SAG P200-2SL PD-2AM P200-2AS P200-REC-S-HS PD-PER PD-RA330-L PD-DA-J6 PD-RA-M PD-CRD-P PD-1A75 PD-2AS PD-1A175 PD-RA155 P200-1A135 PD-CA-64 Primado2 P200-3GAL P200-RA135 PD-SA-S P200-2SS PD-2SS PD-DA-P P200-3GAS P200-PER P200-1A155 P200-OSC-S-HS PD-RA135

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198