BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PSN REV FEM BOX PRV RH 9/9+

    Reg #: 3009887475 · FEI: 3009887475 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Complexus Medical
    Registration Number
    3009887475
    FEI Number
    3009887475
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    55980 Russell Industrial Pkwy
    City
    Mishawaka
    State
    IN
    ZIP
    46545
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191625

    Owner / Operator

    Firm Name
    Complexus Medical
    Operator Number
    10042212
    Address
    55980 Russell Industrial Parkway
    City
    Mishawaka
    State
    IN
    Postal Code
    46545
    Country
    US
    Correspondent
    Michael Behrens

    Products

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

    Proprietary Names

    PSN REV FEM BOX PRV RH 9/9+ PSN REV REAMER ALIGN GUIDE PSN REV FEM BOX PRV RH 5/5+ PSN REV DR HANDLE PSN REV FEM BOX PRV RH 7/7+ PSN REV FEM BOX PRV LH 7/7+ PSN REV QC HANDLE PSN REV FEM BOX PRV LH 5/5+ PSN REV FEM BOX PRV LH 11/11+ PSN REV FEM BOX PRV LH 3/3+ PSN REV FEM BOX PRV RH 3/3+ PSN REV FEM BOX PRV LH 13/13+ PSN REV FEM BOX PRV LH 1/1+ PSN REV FEM BOX PRV LH 9/9+ PSN REV FEM BOX PRV RH 13/13+ PSN REV FEM BOX PRV RH 1/1+ PSN REV FEM BOX PRV RH 11/11+ PSN REV T-HANDLE

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)