K254274
- 510(k) number
- K254274
- Device name
- ARx® SAI Implant System
- Applicant
- Life Spine, Inc. IL · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2026-04-16
- Date received
- 2025-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K254274.pdf
Official FDA record: K254274
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.