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U.S. Department of Health and Human Services

Product Classification
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Device vertebral body tethering system
Definition Anterior-based stabilization or correction of juvenile or adolescent idiopathic scoliosis without the use of fusion
Physical State Polymeric flexible cord, metallic bone screws, and other related accessories
Technical Method The system of a flexible cord and fixation elements (e.g., bone screws) to provide stabilization or correction of the spine
Target Area Pediatric spine
Review Panel Orthopedic
Product CodeQHP
Premarket Review Spinal Devices (DHT6B)
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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