BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ORTHOASCENT LLC

    Reg #: 3032542289 · FEI: 3032542289 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

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    Registration Details

    Registration Name
    ORTHOASCENT LLC
    Registration Number
    3032542289
    FEI Number
    3032542289
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    9035 Wadsworth Pkwy Ste 1000
    City
    Westminster
    State
    CO
    ZIP
    80021
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK241083

    Owner / Operator

    Firm Name
    OrthoAscent LLC
    Operator Number
    10091190
    Address
    9035 Wadsworth Pkwy #1000
    City
    Westminster
    State
    CO
    Postal Code
    80021
    Country
    US
    Correspondent
    Mike A Masters

    Products

    Device Name Product Code
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Platelet And Plasma Separator For Bone Graft Handling ORG

    Proprietary Names

    Ascent Flexx BMC Ascent Flexx PRP

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility