BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Micron II CTR PORP Monlithic All Titanium

    Reg #: 3011050570 · FEI: 3011050570 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Gyrus ACMI, Inc.
    Registration Number
    3011050570
    FEI Number
    3011050570
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9600 Louisiana Ave North
    City
    Brooklyn Park
    State
    MN
    ZIP
    55445
    Country
    US

    Regulatory Submissions

    510(k) Number
    K002737

    Owner / Operator

    Firm Name
    OLYMPUS CORPORATION
    Operator Number
    9067818
    Address
    2951 ISHIKAWA-CHO
    City
    HACHIOJI-SHI
    State
    Tokyo
    Postal Code
    192-8507
    Country
    JP

    Products

    Device Name Product Code
    Prosthesis, Partial Ossicular Replacement ETB
    Replacement, Ossicular Prosthesis, Total ETA

    Proprietary Names

    Micron II CTR PORP Monlithic All Titanium Micron II OCTR PORP Monolithic All Titanium Micron II OCTR All Titanium TORP Adj. Micron Ti TORP Micron II CTR TORP Monolithic All Titanium

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198