BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CATALYST ORTHOSCIENCE Inc

    Reg #: 3012552981 · FEI: 3012552981 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    CATALYST ORTHOSCIENCE Inc
    Registration Number
    3012552981
    FEI Number
    3012552981
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    14710 Tamiami Trail N., Suite #102
    City
    Naples
    State
    FL
    ZIP
    34110
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191811

    Owner / Operator

    Firm Name
    Catalyst Orthoscience
    Operator Number
    10051942
    Address
    14710 Tamiami Trail N., Suite #102
    City
    Naples
    State
    FL
    Postal Code
    34110
    Country
    US
    Correspondent
    Dale Davison

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    Catalyst Shoulder Archer CSR Total Shoulder System Catalyst F1x Shoulder System Catalyst R1 Reverse Shoulder System CSR Catalyst EA Convertible Stemmed Shoulder Catalyst CSR 3 Peg Glenoids Catalyst CSR Shoulder System Archer R1 Reverse Shoulder System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility