BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FIRST ARTICLE INC

    Reg #: 3010032903 · FEI: 3010032903 · Expires 2026
    View on FDA
    Products
    30
    Proprietary Names
    52
    Establishment Types
    1
    Classifications
    30

    Registration Details

    Registration Name
    FIRST ARTICLE INC
    Registration Number
    3010032903
    FEI Number
    3010032903
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    150 S Front St Suite B
    City
    Souderton
    State
    PA
    ZIP
    18964
    Country
    US

    Owner / Operator

    Firm Name
    First Article MFG LLC
    Operator Number
    10095684
    Address
    150 South Front Street Ste. B
    City
    Souderton
    State
    PA
    Postal Code
    18964
    Country
    US
    Correspondent
    Rob Simons

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Arthroscope HRX
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spinal Pedicle Fixation MNI
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Spinal Vertebral Body Replacement Device MQP
    Spinal Vertebral Body Replacement Device - Cervical PLR
    Orthopedic Stereotaxic Instrument OLO
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Intervertebral Fusion Device With Bone Graft, Thoracic PHM
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Subsystem, Water Purification FIP
    Orthosis, Spine, Plate, Laminoplasty, Metal NQW
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Neurological Stereotaxic Instrument HAW
    Posterior Cervical Screw System NKG
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Bone Fixation Cerclage, Sublaminar OWI
    Detector And Alarm, Arrhythmia DSI
    Sacroiliac Joint Fixation OUR
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    Spinous Process Plate PEK
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Posterior Metal/Polymer Spinal System, Fusion NQP
    Bone Cement, Posterior Screw Augmentation PML
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    System, Facet Screw Spinal Device MRW
    Prosthesis, Elbow, Hemi-, Radial, Polymer KWI

    Proprietary Names

    TRUSS PROVIDENCE CROSSWAY PROTEX CT RISE ELLIPSE FORTIFY - Large Excelsius GPS CONTINENTAL REVERE 5.5 Deformity Ti System CITADEL ELSA REVOLVE RELIEVE REVERE 5.5 Degen Ti System MAGNIFY REVERE 4.5 Stabilization System QUARTEX LATIS PRESERVE ACDF System SILC Fixation System SI-LOK Select ANTHEM Ti Proximal Humerus Fracture System SP-Fix COLONIAL InterContinental COALITION TRANSITION ASSURE SI-LOK CREO DLX Deformity Stabilization System REVERE ADDITION INDEPENDENCE Guided Instruments CREO 4.75mm Threaded CoCr Deformity Stabilization System AERIAL BEACON Posted Screw System ASSURE-X REVERE 6.35 Degen Ti System COALITION MIS CREO AMP 5.5 Stabilization System TRANSCONTINENTAL REVLOK CALIBER HAVEN UNIFY XPand CREO ADDITION CORRIDOR SIGNATURE COLOSSEUM PIVOT MIS System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)