BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CULVER TOOL & ENGINEERING

    Reg #: 3010047454 · FEI: 3010047454 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    CULVER TOOL & ENGINEERING
    Registration Number
    3010047454
    FEI Number
    3010047454
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1901 Walter Glaub Dr, 2121 Walter Glaub Dr
    City
    Plymouth
    State
    IN
    ZIP
    46563
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130176

    Owner / Operator

    Firm Name
    Culver Tool & Engineering LLC dba SpiTrex CTE
    Operator Number
    10043008
    Address
    2121 Walter Glaub Dr
    City
    Plymouth
    State
    IN
    Postal Code
    46563
    Country
    US
    Correspondent
    Heather R Houin

    Products

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

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)