BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    07-951-33 Smart Fix Head Pin Standard

    Reg #: 9680242 · FEI: 3009504761 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    34
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MIZUHO Corporation Gosen Factory
    Registration Number
    9680242
    FEI Number
    3009504761
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3631-14, Akomi
    City
    Gosen Niigata
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K821772

    Owner / Operator

    Firm Name
    MIZUHO Corporation
    Operator Number
    9007414
    Address
    3-30-13 HONGO
    City
    BUNKYO-KU
    State
    Tokyo
    Postal Code
    1130033
    Country
    JP

    US Agent

    Business Name
    MIZUHO AMERICA, INC.
    Contact Name
    RICHARD CHADWICK
    Address
    30057 AHERN AVENUE
    City
    Union City
    State
    CA
    ZIP
    94587
    Country
    US
    Email
    [email protected]
    Phone
    510 3244500 ext. 150

    Products

    Device Name Product Code
    Holder, Head, Neurosurgical (Skull Clamp) HBL

    Proprietary Names

    07-951-33 Smart Fix Head Pin Standard 07-951-34 Smart Fix Head Pin Long 07-951-11 Smart Fix C Holder 07-951-00MM Head Holder 07-952-01 Head Arm Base 07-952-05 Table Attachment for 2080 07-981-02 Basal Frame/Semi-circular Frame 07-951-15 Smart Fix Stopper Sleeve 08-075-10 Mayfield Adaptor 07-955-01 Slide Adjuster for Retractor 07-951-12 Smart Fix Joint Box (Including 2 Fixing Screws) 07-951-01 Head Pin, Standard 07-951-03MM Head Pin, Short Tip, for Pediatric, SUS 07-953-01 Sitting Position Frame with Side Rail Clamp 07-952-00 Table Attachment 07-951-01MM Head Pin, Standard, SUS 07-952-06 Table Attachment for 3080 07-981-10 Quarter Frame 07-951-02MM Head Pin, Short Tip, for Adult, SUS 07-981-06 Instrument Receptacle 07-981-03 Hand Rest 07-981-04 Adjustable Hand Rest with Dome Screw 07-981-09 Adjustable Hand Rest with Slide 07-981-07 Cotton Plate 07-982-02 Smart Fix Basic Set 07-952-06A Table Attachment for 3080, Outside 07-983-05 Retractor Slide Adjustor 07-983-03 Hand Rest R 07-983-07 Sub Hole Attachment 07-983-02 Frame Unit 07-983-04 Hand Rest L 07-983-06 Spring Hook Adjustor 07-983-15 Retractor Slide Adjustor II 07-983-08 Cotton Plate Adjustor

    Establishment Types

    Manufacture Medical Device