BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ZS 810-075 Intra-Sacral 1/4" SS Rod - 75mm

    Reg #: 1649379 · FEI: 3000718490 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BANISTER TOOL, INC.
    Registration Number
    1649379
    FEI Number
    3000718490
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3009 A W Grimes Blvd
    City
    Pflugerville
    State
    TX
    ZIP
    78660
    Country
    US

    Regulatory Submissions

    510(k) Number
    K964404

    Owner / Operator

    Firm Name
    Banister Tool, Inc.
    Operator Number
    10042616
    Address
    3009 A W Grimes Blvd
    City
    Pflugerville
    State
    TX
    Postal Code
    78660
    Country
    US
    Correspondent
    Burke Ramsay

    Products

    Device Name Product Code
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Appliance, Fixation, Spinal Interlaminal KWP

    Proprietary Names

    ZS 810-075 Intra-Sacral 1/4" SS Rod - 75mm ZS 810-450 Intra-Sacral 1/4" SS Rod - 450mm ZS 810-125 Intra-Sacral 1/4" SS Rod - 125mm ZS 810-300 Intra-Sacral 1/4" SS Rod - 300mm ZS 810-100 Intra-Sacral 1/4" SS Rod - 100mm ZS 810-050 Intra-Sacral 1/4" SS rod - 50mm

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)