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U.S. Department of Health and Human Services

Product Classification

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Device posterior ratcheting rod system
Definition Stabilization or correction of adolescent idiopathic scoliosis without the use of fusion.
Physical State Metallic ratcheting rod, pedicle screws, and other related accessories.
Technical Method The system of a ratcheting rod and fixation elements (e.g., pedicle screws) provides stabilization or correction of the spine.
Target Area Pediatric spine.
Review Panel Orthopedic
Product CodeQGP
Premarket Review Orthopedic Devices (OHT6)
Spinal Devices (DHT6B)
Not Classified Reason HDE
Submission Type HDE - Humanitarian Device Exemption
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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