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U.S. Department of Health and Human Services

Product Classification
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Device spinal fixation 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
Review Panel Orthopedic
Product CodePWG
Premarket Review Office of Orthopedic Devices (OHT6)
Spinal Devices (DHT6B)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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