BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CUTTING EDGE SPINE

    Reg #: 3009129735 · FEI: 3009129735 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    CUTTING EDGE SPINE
    Registration Number
    3009129735
    FEI Number
    3009129735
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6012 Waxhaw Highway
    City
    Mineral Spgs
    State
    NC
    ZIP
    28108
    Country
    US

    Regulatory Submissions

    510(k) Number
    K214123

    Owner / Operator

    Firm Name
    Cutting Edge Spine
    Operator Number
    10036880
    Address
    6012 Waxhaw hwy
    City
    Mineral Springs
    State
    NC
    Postal Code
    28108
    Country
    US
    Correspondent
    Brad Roof

    Products

    Device Name Product Code
    Sacroiliac Joint Fixation OUR
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP

    Proprietary Names

    T-FIX™3Dsi Joint Fusion System EVOS Lumbar Interbody System EVOL®ha-C Cervical Interbody System EVOL®ha-D Lateral Interbody Fusion System EVOLha-LIF Interbody System EVOL® Lumbar Interbody System EVOL®SI Joint Fusion System EVOL®ha-Hyper C Cervical Interbody System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device