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U.S. Department of Health and Human Services

Product Classification

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Device spinal fixation system
Regulation Description Pedicle screw spinal system.
Definition Stabilization of the posterior thoracic and lumbar spine.
Physical State The spinal rods and connectors are made of titanium alloy per ASTM standards.
Technical Method The subject spinal rods and connectors attach to the posterior spine with pedicle screws and/ or hooks.
Target Area Posterior thoracic and lumbar spine
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodePWG
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? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible