BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Persona Revision tibial drill guide 19.5 mm

    Reg #: 3011015572 · FEI: 3011015572 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    18
    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
    K191625

    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/Metal/Polymer JWH
    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

    Proprietary Names

    Persona Revision tibial drill guide 19.5 mm Persona Revision femoral valgus alignment guide 6 deg Persona Revision Knee System Persona Revision tibial augment cut guide RH Persona Revision femoral offset stem reamer adapter 3/6 mm Persona Revision femoral sizing/cut guide spacer 15 mm Persona Revision tibial straight stem reamer adapter Persona Revision femoral sizing/cut guide spacer 5 mm Persona Revision epicondylar alignment guide Persona Revision tibial offset stem reamer adapter 3/6 mm Persona Revision femoral straight stem reamer adapter Persona Revision IM tibial resection boom 0 deg Persona Revision tibial augment cut guide LH Persona Revision femoral distal cut guide Persona Revision femoral sizing/cut guide spacer 10 mm Persona Revision IM tibial resection cut guide RH Persona Revision femoral drill guide 19.5 mm Persona Revision IM tibial resection cut guide LH

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)