BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Spine Smith 0101-0105 Cimplicity: PEEK Lordotic (5°) Implant 13mm(W) x 10mm(D) x 10.5mm(H)

    Reg #: 1649379 · FEI: 3000718490 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    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
    K073320

    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, Cervical ODP

    Proprietary Names

    Spine Smith 0101-0105 Cimplicity: PEEK Lordotic (5°) Implant 13mm(W) x 10mm(D) x 10.5mm(H) Spine Smith 0101-0055 Cimplicity: PEEK Lordotic (5°) Implant 13mm(W) x 10mm(D) x 5.5mm(H) Spine Smith 0101-0075 Cimplicity: PEEK Lordotic (5°) Implant 13mm(W) x 10mm(D) x 7.5mm(H) Spine Smith 0106-0075 Cimplicity: PEEK Lordotic (5°) Implant 17mm(W) x 14mm(D) x 7.5mm(H) Spine Smith 0101-0085 Cimplicity: PEEK Lordotic (5°) Implant 13mm(W) x 10mm(D) x 8.5mm(H) Spine Smith 0101-0115 Cimplicity: PEEK Lordotic (5°) Implant 13mm(W) x 10mm(D) x 11.5mm(H) Spine Smith 0106-0105 Cimplicity: PEEK Lordotic (5°) Implant 17mm(W) x 14mm(D) x 10.5mm(H) Spine Smith 0106-0055 Cimplicity: PEEK Lordotic (5°) Implant 17mm(W) x 14mm(D) x 5.5mm(H) Spine Smith 0101-0095 Cimplicity: PEEK Lordotic (5°) Implant 13mm(W) x 10mm(D) x 9.5mm(H) Spine Smith 0106-0095 Cimplicity: PEEK Lordotic (5°) Implant 17mm(W) x 14mm(D) x 9.5mm(H) Spine Smith 0106-0065 Cimplicity: PEEK Lordotic (5°) Implant 17mm(W) x 14mm(D) x 6.5mm(H) Spine Smith 0106-0085 Cimplicity: PEEK Lordotic (5°) Implant 17mm(W) x 14mm(D) x 8.5mm(H) Spine Smith 0101-0065 Cimplicity: PEEK Lordotic (5°) Implant 13mm(W) x 10mm(D) x 6.5mm(H)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)