K251154
- 510(k) number
- K251154
- Device name
- RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments
- Applicant
- Ht Medical D.B.A. Xenix Medical FL · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2025-06-12
- Date received
- 2025-04-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K251154.pdf
Official FDA record: K251154
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.