K250582
- 510(k) number
- K250582
- Device name
- COLONNADE Posterior Screw Fixation System
- Applicant
- CG Bio Co., Ltd. KR
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2025-05-08
- Date received
- 2025-02-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K250582.pdf
Official FDA record: K250582
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.