K252729
- 510(k) number
- K252729
- Device name
- Universal Spinal System
- Applicant
- Double Medical Technology, Inc. CN
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2025-11-18
- Date received
- 2025-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K252729.pdf
Official FDA record: K252729
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.