BEUDAMED
    FDA Registration Active 🇺🇸 United States

    A400 Hip System

    Reg #: 1835251 · FEI: 3000205591 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    NGInstruments, Inc dba Avalign Cutting Instruments
    Registration Number
    1835251
    FEI Number
    3000205591
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4643 N State Road 15
    City
    Warsaw
    State
    IN
    ZIP
    46582
    Country
    US

    Regulatory Submissions

    510(k) Number
    K112897

    Owner / Operator

    Firm Name
    NG Instruments, Inc dba Avalign Cutting Instruments
    Operator Number
    10042855
    Address
    4643 North State Road 15
    City
    Warsaw
    State
    IN
    Postal Code
    46582
    Country
    US
    Correspondent
    Heidi Funston

    Products

    Device Name Product Code
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO

    Proprietary Names

    A400 Hip System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)