BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MAX - Intervertebral fusion device with bone graft, lumbar OVD - Intervertebral fusion device with integrated fixation, lumbar

    Reg #: 3000170817 · FEI: 3000170817 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Acero Precision
    Registration Number
    3000170817
    FEI Number
    3000170817
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1340 Enterprise Drive, Suite 100
    City
    West Chester
    State
    PA
    ZIP
    19380
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191834

    Owner / Operator

    Firm Name
    ACERO PRECISION
    Operator Number
    9072046
    Address
    1340 Enterprise Drive, Suite 100
    City
    West Chester
    State
    PA
    Postal Code
    19380
    Country
    US

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD

    Proprietary Names

    MAX - Intervertebral fusion device with bone graft, lumbar OVD - Intervertebral fusion device with integrated fixation, lumbar

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)