# K190317: Zavation Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Zavation Medical Products, LLC
- Decided: Apr 11, 2019 after 57 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K211113: Zavation Spinal System (2021), 4 descendants of its own
- K222614: Zavation Spinal System (2022), 3 descendants of its own
- K243908: Tiger 2 System (2025), 1 descendant of its own
- K253943: Tiger 2 System (2026), 0 descendants of its own
- K231811: Zavation Connector System (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K190317
Methodology: https://510kreport.com/methodology