BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Swedge Pedicle Screw System

    Reg #: 3012770122 · FEI: 3012770122 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SPINAL RESOURCES INC
    Registration Number
    3012770122
    FEI Number
    3012770122
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5975 North Federal Highway, Suite 250
    City
    Fort Lauderdale
    State
    FL
    ZIP
    33308
    Country
    US

    Regulatory Submissions

    510(k) Number
    K170045

    Owner / Operator

    Firm Name
    Spinal Resources Inc
    Operator Number
    10054229
    Address
    5975 North Federal Highway, Suite 250
    City
    Fort Lauderdale
    State
    FL
    Postal Code
    33308
    Country
    US
    Correspondent
    Bernie Bedor

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    Swedge Pedicle Screw System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198