K253045
- 510(k) number
- K253045
- Device name
- Socko Vimax Spinal Fixation System
- Applicant
- Socko Medical Co., Ltd. TW
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2026-06-17
- Date received
- 2025-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253045.pdf
Official FDA record: K253045
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.