K252437
- 510(k) number
- K252437
- Device name
- JAZZ Spinal System
- Applicant
- Implanet FR
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2025-08-28
- Date received
- 2025-08-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K252437.pdf
Official FDA record: K252437
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.