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U.S. Department of Health and Human Services

Product Classification

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Device posterior metal/polymer spinal system, fusion
Regulation Description Pedicle screw spinal system.
Definition This device is a posterior spinal system that contains polymer and metal components.This spinal system is to be used with bone graft and is an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeNQP
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
Third Party Review Not Third Party Eligible
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