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U.S. Department of Health and Human Services

Product Classification

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Device orthosis, spinal pedicle fixation, for degenerative disc disease
Regulation Description Pedicle screw spinal system.
Definition Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at l5-s1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeNKB
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 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Spinal System 510(k)s - Guidance for Industry and FDA Staff
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible