← FDA Medical Device Classifications
Thoracolumbosacral Pedicle Screw System
NKB · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3070
Classification
- FDA Product Code
NKB- 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 provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
Market data
- Cleared 510(k) submissions
- 896
- Registered establishments
- 406
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown