K243908
- 510(k) number
- K243908
- Device name
- Tiger 2 System
- Applicant
- Zavation Medical Products, LLC MS · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2025-02-03
- Date received
- 2024-12-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K243908.pdf
Official FDA record: K243908
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.