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510(k) Data Aggregation

    K Number
    K181995
    Device Name
    Chiral Surgical Pedicle Screw System
    Manufacturer
    Date Cleared
    2018-09-20

    (56 days)

    Product Code
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    Chiral Surgical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Chiral Surgical Pedicle Screw System is a posterior non-cervical pedicle screw system intended for use as an adjunct to fusion in patients with degenerative spondylolisthesis (Grade 3 and 4) with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis) of the lumbosacral spine vertebra and implants are removable after the attainment of a solid fusion. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.
    Device Description
    The Chiral Surgical Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, nuts, and a transverse (cross) connectors. The Chiral Surgical Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Chiral Surgical Pedicle Screw System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136 or Cobalt Chrome that conforms to ASTM F1537. Various sizes of these implants are available.
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