BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Extremity All Suture System

    Reg #: 3015151147 · FEI: 3015151147 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    BOULDER BIOMED LLC
    Registration Number
    3015151147
    FEI Number
    3015151147
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5421 Western Avenue
    City
    Boulder
    State
    CO
    ZIP
    80301
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241695

    Owner / Operator

    Firm Name
    Boulder BioMed dba Boulder iQ
    Operator Number
    10058905
    Address
    5421 Western Avenue
    City
    Boulder
    State
    CO
    Postal Code
    80301
    Country
    US
    Correspondent
    James F Kasic

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC
    Pin, Fixation, Smooth HTY
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Proprietary Names

    Extremity All Suture System

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device for Another Party (Contract Manufacturer)