BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Spine Smith 0601-0090 Cynch TLIF: 5° x 11mm x 30mm x 9mm

    Reg #: 1649379 · FEI: 3000718490 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    122
    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
    K090376

    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
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX

    Proprietary Names

    Spine Smith 0601-0090 Cynch TLIF: 5° x 11mm x 30mm x 9mm Spine Smith 0609-2308-06 Cynch Lordotic TPLIF: 9mm x 23mm x 8mm x 6° Spine Smith 0611-3311 Cynch Straight TPLIF: 11mm x 33mm x 11mm Spine Smith 0611-2308-06 Cynch Lordotic TPLIF: 11mm x 23mm x 8mm x 6° Spine Smith 0611-2810-06 Cynch Lordotic TPLIF: 11mm x 28mm x 10mm x 6° Spine Smith 0602-0110 Cynch TLIF: 5° x 11mm x 25mm x 11mm Spine Smith 0611-3307-06 Cynch Lordotic TPLIF: 11mm x 33mm x 7mm x 6° Spine Smith 0611-2811-06 Cynch Lordotic TPLIF: 11mm x 28mm x 11mm x 6° Spine Smith 0609-2808 Cynch Straight TPLIF: 9mm x 28mm x 8mm Spine Smith 0609-2815-06 Cynch Lordotic TPLIF: 9mm x 28mm x 15mm x 6° Spine Smith 0609-3312 Cynch Straight TPLIF: 9mm x 33mm x 12mm Spine Smith 0611-2309-06 Cynch Lordotic TPLIF: 11mm x 23mm x 9mm x 6° Spine Smith 0602-0140 Cynch TLIF: 5° x 11mm x 25mm x 14mm Spine Smith 0609-3308 Cynch Straight TPLIF: 9mm x 33mm x 8mm Spine Smith 0611-2315-06 Cynch Lordotic TPLIF: 11mm x 23mm x 15mm x 6° Spine Smith 0609-2315-06 Cynch Lordotic TPLIF: 9mm x 23mm x 15mm x 6° Spine Smith 0611-3313 Cynch Straight TPLIF: 11mm x 33mm x 13mm Spine Smith 0611-3308 Cynch Straight TPLIF: 11mm x 33mm x 8mm Spine Smith 0609-2314 Cynch Straight TPLIF: 9mm x 23mm x 14mm Spine Smith 0611-3313-06 Cynch Lordotic TPLIF: 11mm x 33mm x 13mm x 6° Spine Smith 0609-3310 Cynch Straight TPLIF: 9mm x 33mm x 10mm Spine Smith 0609-2308 Cynch Straight TPLIF: 9mm x 23mm x 8mm Spine Smith 0609-2810 Cynch Straight TPLIF: 9mm x 28mm x 10mm Spine Smith 0609-3315-06 Cynch Lordotic TPLIF: 9mm x 33mm x 15mm x 6° Spine Smith 0602-0070 Cynch TLIF: 5° x 11mm x 25mm x 7mm Spine Smith 0609-2309-06 Cynch Lordotic TPLIF: 9mm x 23mm x 9mm x 6° Spine Smith 0609-3309-06 Cynch Lordotic TPLIF: 9mm x 33mm x 9mm x 6° Spine Smith 0611-3314 Cynch Straight TPLIF: 11mm x 33mm x 14mm Spine Smith 0611-2310 Cynch Straight TPLIF: 11mm x 23mm x 10mm Spine Smith 0611-2814 Cynch Straight TPLIF: 11mm x 28mm x 14mm Spine Smith 0601-0120 Cynch TLIF: 5° x 11mm x 30mm x 12mm Spine Smith 0601-0130 Cynch TLIF: 5° x 11mm x 30mm x 13mm Spine Smith 0609-2307-06 Cynch Lordotic TPLIF: 9mm x 23mm x 7mm x 6° Spine Smith 0611-2812-06 Cynch Lordotic TPLIF: 11mm x 28mm x 12mm x 6° Spine Smith 0602-0120 Cynch TLIF: 5° x 11mm x 25mm x 12mm Spine Smith 0601-0150 Cynch TLIF: 5° x 11mm x 30mm x 15mm Spine Smith 0609-2313 Cynch Straight TPLIF: 9mm x 23mm x 13mm Spine Smith 0611-3312 Cynch Straight TPLIF: 11mm x 33mm x 12mm Spine Smith 0611-2813 Cynch Straight TPLIF: 11mm x 28mm x 13mm Spine Smith 0611-2810 Cynch Straight TPLIF: 11mm x 28mm x 10mm Spine Smith 0602-0100 Cynch TLIF: 5° x 11mm x 25mm x 10mm Spine Smith 0611-3314-06 Cynch Lordotic TPLIF: 11mm x 33mm x 14mm x 6° Spine Smith 0611-2310-06 Cynch Lordotic TPLIF: 11mm x 23mm x 10mm x 6° Spine Smith 0611-2813-06 Cynch Lordotic TPLIF: 11mm x 28mm x 13mm x 6° Spine Smith 0609-2311 Cynch Straight TPLIF: 9mm x 23mm x 11mm Spine Smith 0609-3312-06 Cynch Lordotic TPLIF: 9mm x 33mm x 12mm x 6° Spine Smith 0611-2808 Cynch Straight TPLIF: 11mm x 28mm x 8mm Spine Smith 0609-2811-06 Cynch Lordotic TPLIF: 9mm x 28mm x 11mm x 6° Spine Smith 0609-2814 Cynch Straight TPLIF: 9mm x 28mm x 14mm Spine Smith 0611-2313 Cynch Straight TPLIF: 11mm x 23mm x 13mm Spine Smith 0602-0060 Cynch TLIF: 5° x 11mm x 25mm x 6mm Spine Smith 0609-2809-06 Cynch Lordotic TPLIF: 9mm x 28mm x 9mm x 6° Spine Smith 0611-3309 Cynch Straight TPLIF: 11mm x 33mm x 9mm Spine Smith 0611-2307-06 Cynch Lordotic TPLIF: 11mm x 23mm x 7mm x 6° Spine Smith 0609-3314 Cynch Straight TPLIF: 9mm x 33mm x 14mm Spine Smith 0611-2311 Cynch Straight TPLIF: 11mm x 23mm x 11mm Spine Smith 0609-2808-06 Cynch Lordotic TPLIF: 9mm x 28mm x 8mm x 6° Spine Smith 0609-2812-06 Cynch Lordotic TPLIF: 9mm x 28mm x 12mm x 6° Spine Smith 0609-3311-06 Cynch Lordotic TPLIF: 9mm x 33mm x 11mm x 6° Spine Smith 0611-2312 Cynch Straight TPLIF: 11mm x 23mm x 12mm Spine Smith 0601-0140 Cynch TLIF: 5° x 11mm x 30mm x 14mm Spine Smith 0609-2312-06 Cynch Lordotic TPLIF: 9mm x 23mm x 12mm x 6° Spine Smith 0611-3311-06 Cynch Lordotic TPLIF: 11mm x 33mm x 11mm x 6° Spine Smith 0609-2809 Cynch Straight TPLIF: 9mm x 28mm x 9mm Spine Smith 0609-3313-06 Cynch Lordotic TPLIF: 9mm x 33mm x 13mm x 6° Spine Smith 0611-2313-06 Cynch Lordotic TPLIF: 11mm x 23mm x 13mm x 6° Spine Smith 0611-2807-06 Cynch Lordotic TPLIF: 11mm x 28mm x 7mm x 6° Spine Smith 0601-0080 Cynch TLIF: 5° x 11mm x 30mm x 8mm Spine Smith 0609-2815 Cynch Straight TPLIF: 9mm x 28mm x 15mm Spine Smith 0609-3308-06 Cynch Lordotic TPLIF: 9mm x 33mm x 8mm x 6° Spine Smith 0611-2314 Cynch Straight TPLIF: 11mm x 23mm x 14mm Spine Smith 0609-2807-06 Cynch Lordotic TPLIF: 9mm x 28mm x 7mm x 6° Spine Smith 0611-3312-06 Cynch Lordotic TPLIF: 11mm x 33mm x 12mm x 6° Spine Smith 0609-3315 Cynch Straight TPLIF: 9mm x 33mm x 15mm Spine Smith 0611-2314-06 Cynch Lordotic TPLIF: 11mm x 23mm x 14mm x 6° Spine Smith 0609-2313-06 Cynch Lordotic TPLIF: 9mm x 23mm x 13mm x 6° Spine Smith 0611-3310-06 Cynch Lordotic TPLIF: 11mm x 33mm x 10mm x 6° Spine Smith 0611-2808-06 Cynch Lordotic TPLIF: 11mm x 28mm x 8mm x 6° Spine Smith 0611-2809-06 Cynch Lordotic TPLIF: 11mm x 28mm x 9mm x 6° Spine Smith 0609-2312 Cynch Straight TPLIF: 9mm x 23mm x 12mm Spine Smith 0609-3314-06 Cynch Lordotic TPLIF: 9mm x 33mm x 14mm x 6° Spine Smith 0602-0130 Cynch TLIF: 5° x 11mm x 25mm x 13mm Spine Smith 0609-2311-06 Cynch Lordotic TPLIF: 9mm x 23mm x 11mm x 6° Spine Smith 0611-3310 Cynch Straight TPLIF: 11mm x 33mm x 10mm Spine Smith 0611-2815-06 Cynch Lordotic TPLIF: 11mm x 28mm x 15mm x 6° Spine Smith 0611-2815 Cynch Straight TPLIF: 11mm x 28mm x 15mm Spine Smith 0601-0110 Cynch TLIF: 5° x 11mm x 30mm x 11mm Spine Smith 0609-2309 Cynch Straight TPLIF: 9mm x 23mm x 9mm Spine Smith 0611-2814-06 Cynch Lordotic TPLIF: 11mm x 28mm x 14mm x 6° Spine Smith 0609-2812 Cynch Straight TPLIF: 9mm x 28mm x 12mm Spine Smith 0609-3309 Cynch Straight TPLIF: 9mm x 33mm x 9mm Spine Smith 0609-2314-06 Cynch Lordotic TPLIF: 9mm x 23mm x 14mm x 6° Spine Smith 0609-3313 Cynch Straight TPLIF: 9mm x 33mm x 13mm Spine Smith 0602-0080 Cynch TLIF: 5° x 11mm x 25mm x 8mm Spine Smith 0609-2813-06 Cynch Lordotic TPLIF: 9mm x 28mm x 13mm x 6° Spine Smith 0611-3315 Cynch Straight TPLIF: 11mm x 33mm x 15mm Spine Smith 0611-2309 Cynch Straight TPLIF: 11mm x 23mm x 9mm Spine Smith 0609-2310-06 Cynch Lordotic TPLIF: 9mm x 23mm x 10mm x 6° Spine Smith 0609-3307 Cynch Straight TPLIF: 9mm x 33mm x 7mm Spine Smith 0609-2810-06 Cynch Lordotic TPLIF: 9mm x 28mm x 10mm x 6° Spine Smith 0611-3315-06 Cynch Lordotic TPLIF: 11mm x 33mm x 15mm x 6° Spine Smith 0609-3310-06 Cynch Lordotic TPLIF: 9mm x 33mm x 10mm x 6° Spine Smith 0611-2315 Cynch Straight TPLIF: 11mm x 23mm x 15mm Spine Smith 0609-2814-06 Cynch Lordotic TPLIF: 9mm x 28mm x 14mm x 6° Spine Smith 0609-2807 Cynch Straight TPLIF: 9mm x 28mm x 7mm Spine Smith 0611-2311-06 Cynch Lordotic TPLIF: 11mm x 23mm x 11mm x 6° Spine Smith 0602-0090 Cynch TLIF: 5° x 11mm x 25mm x 9mm Spine Smith 0611-3308-06 Cynch Lordotic TPLIF: 11mm x 33mm x 8mm x 6° Spine Smith 0611-2312-06 Cynch Lordotic TPLIF: 11mm x 23mm x 12mm x 6° Spine Smith 0611-2812 Cynch Straight TPLIF: 11mm x 28mm x 12mm Spine Smith 0609-2813 Cynch Straight TPLIF: 9mm x 28mm x 13mm Spine Smith 0609-3307-06 Cynch Lordotic TPLIF: 9mm x 33mm x 7mm x 6° Spine Smith 0609-2811 Cynch Straight TPLIF: 9mm x 28mm x 11mm Spine Smith 0609-3311 Cynch Straight TPLIF: 9mm x 33mm x 11mm Spine Smith 0611-2308 Cynch Straight TPLIF: 11mm x 23mm x 8mm Spine Smith 0601-0100 Cynch TLIF: 5° x 11mm x 30mm x 10mm Spine Smith 0609-2310 Cynch Straight TPLIF: 9mm x 23mm x 10mm Spine Smith 0611-2809 Cynch Straight TPLIF: 11mm x 28mm x 9mm Spine Smith 0602-0150 Cynch TLIF: 5° x 11mm x 25mm x 15mm Spine Smith 0609-2315 Cynch Straight TPLIF: 9mm x 23mm x 15mm Spine Smith 0611-3309-06 Cynch Lordotic TPLIF: 11mm x 33mm x 9mm x 6° Spine Smith 0611-2811 Cynch Straight TPLIF: 11mm x 28mm x 11mm

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)