BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DAKOTA ACDF SYSTEM

    Reg #: 3005739886 · FEI: 3005739886 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Precision Spine, Inc.
    Registration Number
    3005739886
    FEI Number
    3005739886
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2050 Executive Dr
    City
    Pearl
    State
    MS
    ZIP
    39208
    Country
    US

    Regulatory Submissions

    510(k) Number
    K203129

    Owner / Operator

    Firm Name
    Spinal USA, Inc.
    Operator Number
    9087328
    Address
    2050 Executive Drive, --
    City
    Pearl
    State
    MS
    Postal Code
    39208
    Country
    US
    Correspondent
    Michael C Dawson

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE

    Proprietary Names

    DAKOTA ACDF SYSTEM

    Establishment Types

    Manufacture Medical Device