Product code OSH
- Device name
- Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3070
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.
- Source
- FDA openFDA device classification dataset