BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ABLE MEDICAL DEVICES

    Reg #: 3014680795 · FEI: 3014680795 · Expires 2026
    View on FDA
    Products
    39
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    39

    Registration Details

    Registration Name
    ABLE MEDICAL DEVICES
    Registration Number
    3014680795
    FEI Number
    3014680795
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    512 Fourth Street
    City
    Gwinn
    State
    MI
    ZIP
    49841
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202889

    Owner / Operator

    Firm Name
    Able Medical Devices
    Operator Number
    10058122
    Address
    512 Fourth Street
    City
    Gwinn
    State
    MI
    Postal Code
    49841
    Country
    US
    Correspondent
    Halie Gibson

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Tamp HXG
    Orthopedic Stereotaxic Instrument OLO
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Spinal Vertebral Body Replacement Device - Cervical PLR
    Spinal Vertebral Body Replacement Device MQP
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    Appliance, Fixation, Spinal Interlaminal KWP
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    Bit, Drill HTW
    Cerclage, Fixation JDQ
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Wrench HXC
    Thoracolumbosacral Pedicle Screw System NKB
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Orthopedic Manual Surgical Instrument LXH
    Guide, Drill, Ligament LXI
    Screwdriver HXX
    Intervertebral Fusion Device With Bone Graft, Thoracic PHM
    System, Facet Screw Spinal Device MRW
    Instrument, Manual, Surgical, General Use MDM
    Pin, Fixation, Smooth HTY
    Posterior Cervical Screw System NKG
    Pliers, Surgical HTC
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    Internal Hinged Elbow Fixator OZI
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Retractor GAD
    Sacroiliac Joint Fixation OUR
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT

    Proprietary Names

    Valkyrie Thoracic Fixation System Valkyrie Rib Thoracic Fixation System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device