BEUDAMED
    FDA Registration Inactive 🇺🇸 United States

    Interwedge

    · Expires 2025
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    FOUNDATION SURGICAL GROUP
    Status
    Inactive
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7327 E Tierra Buena Ln Ste 101
    City
    Scottsdale
    State
    AZ
    ZIP
    85260
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241487

    Owner / Operator

    Firm Name
    Foundation Surgical Group
    Operator Number
    10093677
    Address
    7327 E Tierra Buena Lane, Suite 101
    City
    Scottsdale
    State
    AZ
    Postal Code
    85260
    Country
    US
    Correspondent
    Christopher Reah

    Products

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

    Proprietary Names

    Interwedge

    Establishment Types

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