Search Results
Found 1 results
510(k) Data Aggregation
K Number
K181995Device Name
Chiral Surgical Pedicle Screw System
Manufacturer
Date Cleared
2018-09-20
(56 days)
Product Code
Regulation Number
888.3070Why 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.
Ask a Question
Ask a specific question about this device
Page 1 of 1