BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PSN REV FEM VAL ALGN GDE 6 DEG

    Reg #: 3011015572 · FEI: 3011015572 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    INCIPIO DEVICES
    Registration Number
    3011015572
    FEI Number
    3011015572
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3650 West 200 North
    City
    Huntington
    State
    IN
    ZIP
    46750
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181947

    Owner / Operator

    Firm Name
    Incipio Devices
    Operator Number
    10047511
    Address
    3650 W 200 N
    City
    Huntington
    State
    IN
    Postal Code
    46750
    Country
    US
    Correspondent
    Troy Johnson

    Products

    Device Name Product Code
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    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

    PSN REV FEM VAL ALGN GDE 6 DEG PSN REV TIB OFF STM ADP 3/6 MM STEM EXTRACTOR PSN REV TIB STR STM ADPT PSN REV FEM ROT ALGN GDE PSN REV EXT TAPER IMPT IM TIB RESECTION BOOM 0 DEG PSN REV CNTR-TRQ WRENCH PSN REV FEM DIST CUT GDE PSN REV FEM STR ADPT PSN REV ROTATION ASSESSMNT GDE PSN REV FEM SZ/CT GD SPC 15 MM PSN REV FEM SZ/CTGD SPC 5 MM PSN REV FEM SZ/CT GD SPC 10MM IM TIB RESECTION CUT GUIDE LT PSN REV ALGN ROD ADPT PSN REV FEM STEM PRV ADPT PSN REV TIB AUG CUT GDE RT PSN REV TIB DRL GDE 19.5MM PSN REV FEM OFST ADPT 3/6 MM IM TIB RESECTION CUT GUIDE RT PSN REV FEM DRL GDE 19.5MM PSN REV TIB AUG CUT GDE LT

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)