BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Spine Smith 1103-0080 IN:C2 PEEK Lordotic (6°) Implant 18mm(W) x 15mm(D) x 8mm(H)

    Reg #: 1649379 · FEI: 3000718490 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    21
    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
    K122630

    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 Integrated Fixation, Cervical OVE

    Proprietary Names

    Spine Smith 1103-0080 IN:C2 PEEK Lordotic (6°) Implant 18mm(W) x 15mm(D) x 8mm(H) Spine Smith 1101-0090 IN:C2 PEEK Lordotic (6°) Implant 14mm(W) x 11.5mm(D) x 9mm(H) Spine Smith 1101-0070 IN:C2 PEEK Lordotic (6°) Implant 14mm(W) x 11.5mm(D) x 6.5mm(H) Spine Smith 1103-0090 IN:C2 PEEK Lordotic (6°) Implant 18mm(W) x 15mm(D) x 9mm(H) Spine Smith 1101-0050 IN:C2 PEEK Lordotic (6°) Implant 14mm(W) x 11.5mm(D) x 5mm(H) Spine Smith 1102-0080 IN:C2 PEEK Lordotic (6°) Implant 16mm(W) x 13mm(D) x 8mm(H) Spine Smith 1101-0100 IN:C2 PEEK Lordotic (6°) Implant 14mm(W) x 11.5mm(D) x 10mm(H) Spine Smith 1102-0050 IN:C2 PEEK Lordotic (6°) Implant 16mm(W) x 13mm(D) x 5mm(H) Spine Smith 1103-0100 IN:C2 PEEK Lordotic (6°) Implant 18mm(W) x 15mm(D) x 10mm(H) Spine Smith 1102-0100 IN:C2 PEEK Lordotic (6°) Implant 16mm(W) x 13mm(D) x 10mm(H) Spine Smith 1102-0110 IN:C2 PEEK Lordotic (6°) Implant 16mm(W) x 13mm(D) x 11mm(H) Spine Smith 1101-0110 IN:C2 PEEK Lordotic (6°) Implant 14mm(W) x 11.5mm(D) x 11mm(H) Spine Smith 1103-0060 IN:C2 PEEK Lordotic (6°) Implant 18mm(W) x 15mm(D) x 6mm(H) Spine Smith 1102-0070 IN:C2 PEEK Lordotic (6°) Implant 16mm(W) x 13mm(D) x 7mm(H) Spine Smith 1103-0050 IN:C2 PEEK Lordotic (6°) Implant 18mm(W) x 15mm(D) x 5mm(H) Spine Smith 1103-0070 IN:C2 PEEK Lordotic (6°) Implant 18mm(W) x 15mm(D) x 7mm(H) Spine Smith 1102-0090 IN:C2 PEEK Lordotic (6°) Implant 16mm(W) x 13mm(D) x 9mm(H) Spine Smith 1101-0060 IN:C2 PEEK Lordotic (6°) Implant 14mm(W) x 11.5mm(D) x 6mm(H) Spine Smith 1103-0110 IN:C2 PEEK Lordotic (6°) Implant 18mm(W) x 15mm(D) x 11mm(H) Spine Smith 1101-0080 IN:C2 PEEK Lordotic (6°) Implant 14mm(W) x 11.5mm(D) x 7mm(H) Spine Smith 1102-0060 IN:C2 PEEK Lordotic (6°) Implant 16mm(W) x 13mm(D) x 6mm(H)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)