BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Orthosis, spinal pedicle fixation

    Reg #: 3006404071 · FEI: 3006404071 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    4
    Classifications
    3

    Registration Details

    Registration Name
    SpineSmith Holdings, LLC
    Registration Number
    3006404071
    FEI Number
    3006404071
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4719 South Congress Ave.
    City
    AUSTIN
    State
    TX
    ZIP
    78745
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160722

    Owner / Operator

    Firm Name
    SpineSmith Holdings,LLC
    Operator Number
    9104820
    Address
    4719 South Congress Ave., --
    City
    Austin
    State
    TX
    Postal Code
    78745
    Country
    US
    Correspondent
    Chriselda Martinez

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI

    Proprietary Names

    Orthosis, spinal pedicle fixation Orthosis, spondylolisthesis spinal fixation Thoracolumbosacral pedicle screw system

    Establishment Types

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