K253943
- 510(k) number
- K253943
- Device name
- Tiger 2 System
- Applicant
- Zavation Medical Products, LLC MS · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2026-07-24
- Date received
- 2025-12-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K253943.pdf
Official FDA record: K253943
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.