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U.S. Department of Health and Human Services

Product Classification

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Device thoracolumbosacral pedicle screw system
Regulation Description Thoracolumbosacral pedicle screw system.
Definition Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
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 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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