BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ZS 1804-112 Strut, Small, 12mm

    Reg #: 1649379 · FEI: 3000718490 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    1

    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
    K031672

    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
    Spinal Vertebral Body Replacement Device MQP

    Proprietary Names

    ZS 1804-112 Strut, Small, 12mm ZS 1804-508 Strut, Large, 08mm ZS 1803-14 InFix Endcap, 14MM ZS 1804-114 Strut, Small 14mm ZS 1804-310 Strut, Medium, 10mm ZS 1804-314 Strut, Medium, 14mm ZS 1804-110 Strut, Small, 10mm ZS 1803-08 InFix Endcap, 08MM ZS 1803-12, InFix Endcap, 12MM ZS 1804-308 Strut, Medium, 08mm ZS 1804-512 Strut, Large, 12mm ZS 1803-10 InFix Endcap, 10MM ZS 1804-312 Strut, Medium, 12mm ZS 1804-510 Strut, Large, 10mm ZS 1804-514 Strut, Large, 14mm ZS 1804-108 Strut, Small, 08MM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)