← FDA Medical Device Classifications
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
OSH · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3070
Classification
- FDA Product Code
OSH- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 888.3070
- Review panel
- OR
- Medical specialty
- Orthopedic
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Definition
Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.
Market data
- Cleared 510(k) submissions
- 19
- Registered establishments
- 159
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown