K241494
- 510(k) number
- K241494
- Device name
- Pantheon Pedicle Screw and Iliac Bolt Fixation System
- Applicant
- Pantheon Spinal TX · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-07-26
- Date received
- 2024-05-28
- 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: K241494.pdf
Official FDA record: K241494
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.