K242350
- 510(k) number
- K242350
- Device name
- Spinal Alignment Solutions Pelvic Incidence (PI) Rod System
- Applicant
- Spinal Alignment Solutions, Inc. RI · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-10-28
- Date received
- 2024-08-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K242350.pdf
Official FDA record: K242350
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.