Tiger 2 System— 510(k) K253943
Substantially EquivalentZavation Medical Products, LLC
FDA 510(k) clearance K253943 for Tiger 2 System, Substantially Equivalent on 2026-07-24. Applicant: Zavation Medical Products, LLC. Device class: 2.
Summary
Zavation Medical Products' Tiger 2 System is filed under NKB, thoracolumbosacral pedicle screw systems. The record doesn't list the system's components or sizes.
Class II, 21 CFR 888.3070. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).
Zavation filed from Flowood, Mississippi. Review took 226 calendar days (December 10, 2025 to July 24, 2026).
Clearance details
- Applicant
- Zavation Medical Products, LLC
- Product code
- Product code NKB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Flowood, MS, US
Recent devices under product code NKB
view allMore clearances from Zavation Medical Products, LLC
view allAdverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.