BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Pantheon Spinal LLC

    Reg #: 3010665091 · FEI: 3010665091 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    6

    Registration Details

    Registration Name
    Pantheon Spinal LLC
    Registration Number
    3010665091
    FEI Number
    3010665091
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    40132 Industrial Park Cir Ste 103
    City
    Georgetown
    State
    TX
    ZIP
    78626
    Country
    US

    Regulatory Submissions

    510(k) Number
    K170572

    Owner / Operator

    Firm Name
    Pantheon Spinal LLC
    Operator Number
    10045940
    Address
    40132 Industrial Park Circle, Suite 103
    City
    Georgetown
    State
    TX
    Postal Code
    78626
    Country
    US
    Correspondent
    Dave Lamb

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Appliance, Fixation, Spinal Interlaminal KWP
    Thoracolumbosacral Pedicle Screw System NKB
    Sacroiliac Joint Fixation OUR
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Intervertebral Fusion Device With Bone Graft, Cervical ODP

    Proprietary Names

    Yellowstone Interbody Fusion System Pantheon Spinal IBFD Channel Cervical Interbody Fusion System

    Establishment Types

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