BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Biomet Microfixation Neuro Plating System

    Reg #: 1032347 · FEI: 1032347 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    4
    Classifications
    3

    Registration Details

    Registration Name
    BIOMET MICROFIXATION
    Registration Number
    1032347
    FEI Number
    1032347
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1520 Tradeport Dr
    City
    Jacksonville
    State
    FL
    ZIP
    32218
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121624

    Owner / Operator

    Firm Name
    BIOMET MICROFIXATION
    Operator Number
    1032347
    Address
    1520 TRADEPORT DR., --
    City
    Jacksonville
    State
    FL
    Postal Code
    32218
    Country
    US
    Correspondent
    Jay M Sharma

    Products

    Device Name Product Code
    Fastener, Plate, Cranioplasty HBW
    Plate, Cranioplasty, Preformed, Alterable GWO
    Cover, Burr Hole GXR

    Proprietary Names

    Biomet Microfixation Neuro Plating System 1.5mm System CranioCurve 1mm System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device