K243259
- 510(k) number
- K243259
- Device name
- MASADA Modular Spinal Fixation System
- Applicant
- Astura Medical TX · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2025-01-07
- Date received
- 2024-10-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243259.pdf
Official FDA record: K243259
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.