BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Interwedge® Standalone Lateral

    Reg #: 3014967969 · FEI: 3014967969 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PACKAGING COMPLIANCE MEDICAL, LLC
    Registration Number
    3014967969
    FEI Number
    3014967969
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4334 Brockton Dr SE, Suite E
    City
    Kentwood
    State
    MI
    ZIP
    49512
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241487

    Owner / Operator

    Firm Name
    Packaging Compliance Medical, LLC
    Operator Number
    10082615
    Address
    4334 Brockton Dr SE, Suite E
    City
    Kentwood
    State
    MI
    Postal Code
    49512
    Country
    US
    Correspondent
    Matthew Lapham

    Products

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

    Proprietary Names

    Interwedge® Standalone Lateral

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)