K231655
- 510(k) number
- K231655
- Device name
- 4CIS® Chiron Spinal Fixation System
- Applicant
- Solco Biomedical Co., Ltd. KR
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-11-26
- Date received
- 2023-06-06
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K231655.pdf
Official FDA record: K231655
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.