BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS

    Reg #: 3009185591 · FEI: 3009185591 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CROOM PRECISION MEDICAL
    Registration Number
    3009185591
    FEI Number
    3009185591
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SFADCO Enterprise Centre
    City
    Croom Limerick
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K141056

    Owner / Operator

    Firm Name
    CROOM PRECISION TOOLING LTD
    Operator Number
    10043191
    Address
    SFADCO Enterprise Centre, Croom
    City
    LIMERICK
    State
    IE-LK
    Postal Code
    V35YD39
    Country
    IE

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Dr
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    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/Metal/Polymer JWH

    Proprietary Names

    TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)