K252346
- 510(k) number
- K252346
- Device name
- OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
- Applicant
- Astura Medical TX · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2025-10-21
- Date received
- 2025-07-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K252346.pdf
Official FDA record: K252346
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.