K243004
- 510(k) number
- K243004
- Device name
- Xpine Spinal Fixation System
- Applicant
- Jeil Medical Corporation KR
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-11-08
- Date received
- 2024-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K243004.pdf
Official FDA record: K243004
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.