BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Prosthesis

    Reg #: 3013413393 · FEI: 3013413393 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Avalign Additive / Slice Manufacturing Studios
    Registration Number
    3013413393
    FEI Number
    3013413393
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1810 Triplett Blvd
    City
    Akron
    State
    OH
    ZIP
    44306
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161184

    Owner / Operator

    Firm Name
    Avalign Instruments & Implants
    Operator Number
    9008280
    Address
    8727 Clinton Park Drive, --
    City
    Fort Wayne
    State
    IN
    Postal Code
    46825
    Country
    US
    Correspondent
    Jeff Robinson

    Products

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

    Proprietary Names

    Prosthesis

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)