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U.S. Department of Health and Human Services

Product Classification
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Device pedicle screw spinal system, adolescent idiopathic scoliosis
Regulation Description Thoracolumbosacral pedicle screw system.
Definition Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.
Physical State Bone screws, rods, and hooks intended to stabilize the spine as an adjunct to fusion
Technical Method Acts as a spinal fusion system with autograft and/or allograft to stabilize the spine as an adjunct to fusion to treat adolescent idiopathic scoliosis
Target Area Posterior, non-cervical spinal column in adolescent patients
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeOSH
Premarket Review Office of Orthopedic Devices (OHT6)
Spinal Devices (DHT6B)
Submission Type 510(k)
Regulation Number 888.3070
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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