BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NexGen Complete Knee Solution - Rotating Hinge Knee

    Reg #: 1000200989 · FEI: 1000200989 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Paragon Medical - Dayton
    Registration Number
    1000200989
    FEI Number
    1000200989
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4201 Little York Rd
    City
    Dayton
    State
    OH
    ZIP
    45414
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173057

    Owner / Operator

    Firm Name
    Paragon Medical Inc.
    Operator Number
    10043017
    Address
    8 Matchett Dr.
    City
    Pierceton
    State
    IN
    Postal Code
    46562
    Country
    US
    Correspondent
    James F Rogers

    Products

    Device Name Product Code
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    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

    NexGen Complete Knee Solution - Rotating Hinge Knee ZIMMER KNEE JOINT REPLACEMENT PROSTHESES-MR LABELING

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)