BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ZS 2666-090921 Trial 09MM X 09MM X 21MM

    Reg #: 1649379 · FEI: 3000718490 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    58
    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

    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
    Guide, Surgical, Instrument FZX

    Proprietary Names

    ZS 2666-090921 Trial 09MM X 09MM X 21MM ZS 2666-131125 Trial 13MM X 11MM X 25MM ZS 2665-1-15 Traxis Trial, 15MM ZS 2665-1-09 Traxis Trial, 9MM ZS 1879-100 Guide-Small ZS 2666-110921 Trial 11MM X 09MM X 21MM ZS 1857-300 Endplate Trial, Medium Pioneer 431-278 Locking Guide, Single Barrel, 10° Right ZS 2665-1-13 Traxis Trial, 13MM ZS 1857-500 Endplate Trial, Large ZS 2665-1-11 Traxis Trial, 11MM Pioneer 0254-0021 Cequence, Constrained SB Drill Guide II ZS 1874-300 Guide Impact Cap, Medium ZS 2666-110925 Trial 11MM X 09MM X 25MM Pioneer 431-250 Locking Guide, Single Barrel, 10° Left ZS 601-019-S50 Pedicle Scre Marker- 50mm ZS 1874-500 Guide Impact Cap, Large Pioneer 24-DBGUIDE-S-0 Guide, Standard, Double Barrel, 0° Pioneer 24-SBGUIDE-S-0 Guide, Standard, Single Barrel, 0° ZS 1874-100 Guide Impact Cap, Small Pioneer 24-DBGUIDE-S-10 Guide, Standard, Double Barrel, 10° ZS 1857-100 Endplate Trial, Small ZS 2666-090925 Trial 09MM X 09MM X 25MM Pioneer 0254-2011 Cequence, DB Drill Guide, End Holes ZS 7076-01 Nex-Link Oct Flexible Instrument Guidance Tool Integra OSG-200-10P PIP, Proximal Cut Guide, Sz. 10 Integra OSG-200-10PV PIP Prox Cut Guide, Volar Appr, Sz. 10 Integra OSG-200-40P PIP, Proximal Cut Guide, Sz. 40 Integra OSG-200-20P PIP, Proximal Cut Guide, Sz. 20 Integra OSG-200-30PV PIP Prox Cut Guide, Volar Appr, Sz. 30 Integra OSG-200-20PV PIP Prox Cut Guide, Volar Appr, Sz. 20 Ascension OSG-350-01 Osteotomy Cut Guide, MRH Integra OSG-200-00 PIP Vertical Cut Guide Integra OSG-200-40PV PIP Prox Cut Guide, Volar Appr, Sz. 40 Integra OSG-200-30P PIP, Proximal Cut Guide, Sz. 30 Ascension ALG-100-00 Alignment Guide RSS Double Drill Guide DWG-04-0961-077-501 Definitive Stem RSS Reamer Guide Body, STD DWG-0960-044-502 MUH Osteotomy Guide DWG-04-605-008 Definitive Stem RSS Reamer Guide Body, LRG DWG-0960-044-502 DRUJ Osteotomy Guide DWG-04-615-001 Definitive Stem RSS Reamer Guide Body, SML DWG-0960-044-502 Talar Chamfer Drill Guide DWG-04-1020-4033 Pioneer 431-280 Locking Guide, Single Barrel, 0° ZS 2666-111125 Trial 11MM X 11MM X 25MM ZS 2666-151121 Trial 15MM X 11MM X 21MM ZS 2666-151125 Trial 15MM X 11MM X 25MM ZS 485-1 Fixed ACP Double Barrel Drill Guide- Slimline Pioneer 24-SBGUIDE-S-10-R Guide, Standard, Single Barrel, 10° Right ZS 1879-500 Guide-Large Pioneer 24-SBGUIDE-S-10-L Guide, Standard, Single Barrel, 10° Left ZS 2666-131121 Trial 13MM X 11MM X 21MM ZS 2665-1-07 Traxis Trial, 7MM ZS 2159-6 Guide Tube ZS 1879-300 Guide-Medium Pioneer 0254-2010 Cequence, DB Drill Guide, Middle Holes ZS 2666-111121 Trial 11MM X 11MM X 21MM ZS 601-019-S Pedicle Screw Marker 30mm

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)