• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device pedicle screw placement guide
Regulation Description Pedicle screw spinal system.
Definition A pedicle screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of pedicle screws that are used to anchor pedicle screw spinal systems onto the posterior elements of the spine.The device utilizes anatomic landmarks that are identifiable on pre-operative imaging scans.
Physical State A pedicle screw placement guide, made of polymeric or metallic material, which contains a patient-matched surface that is congruent to the mating surface of the posterior elements of the spine.
Technical Method The device consists of a both a software and hardware component. The software component generates a pre-operative plan based on medical imaging data. The hardware component consists of a patient-matched guide that is positioned onto the posterior elements of the spine. The guide is used to place pedicle screws in a pre-operatively desired orientation.
Target Area Spine
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodePQC
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Posterior Spine Devices Branch (PSDB)
Submission Type 510(k)
Regulation Number 888.3070
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-