BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology

    Reg #: 1834331 · FEI: 1000306340 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PARAGON MEDICAL, INC.
    Registration Number
    1834331
    FEI Number
    1000306340
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8 Matchett Dr.
    City
    PIERCETON
    State
    IN
    ZIP
    46562
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232303

    Owner / Operator

    Firm Name
    Paragon Medical
    Operator Number
    9011072
    Address
    8 Matchett Dr., --
    City
    Pierceton
    State
    IN
    Postal Code
    46562
    Country
    US
    Correspondent
    Stephane Langlois

    Products

    Device Name Product Code
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH

    Proprietary Names

    ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)