BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Blustone Synergy Slate Cervical Interbody Fusion System

    Reg #: 3014019090 · FEI: 3014019090 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BLUSTONE SYNERGY, LLC
    Registration Number
    3014019090
    FEI Number
    3014019090
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5520 Ventana Ct
    City
    Pueblo
    State
    CO
    ZIP
    81005
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171893

    Owner / Operator

    Firm Name
    Blustone Synergy, LLC
    Operator Number
    10055810
    Address
    5520 Ventana Ct.
    City
    Pueblo
    State
    CO
    Postal Code
    81005
    Country
    US
    Correspondent
    Tom Gentry

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP

    Proprietary Names

    Blustone Synergy Slate Cervical Interbody Fusion System Blustone Synergy Obsidian Lumbar Interbody Fusion System Blustone Synergy Magma Lumbar Interbody Fusion System Blustone Synergy Basalt Lumbar Interbody Fusion System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility