BEUDAMED
    FDA Registration Active 🇺🇸 United States

    F1 MPS

    Reg #: 3010663372 · FEI: 3010663372 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    DEGEN MEDICAL
    Registration Number
    3010663372
    FEI Number
    3010663372
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1321C N Cashua Dr
    City
    Florence
    State
    SC
    ZIP
    29501
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142531

    Owner / Operator

    Firm Name
    DeGen Medical
    Operator Number
    10048016
    Address
    1321-C North Cashua Drive
    City
    Florence
    State
    SC
    Postal Code
    29501
    Country
    US
    Correspondent
    Craig Black

    Products

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

    Proprietary Names

    F1 MPS E3

    Establishment Types

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