# K002260: Spina System

- Pathway: 510(k) (Traditional)
- Applicant: North American Medical Corporation (Nam)
- Decided: Aug 25, 2000 after 31 days
- Product code: ITH (Equipment, Traction, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K030060: Spinemed (2003), 10 descendants of its own
- K053223: Triton/Tru-Trac/TX/Triton DTS Traction (2006), 8 descendants of its own
- K151640: Eltrac 471 (2015), 1 descendant of its own
- K214037: Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac (2024), 0 descendants of its own
- K222912: c1Trac (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K002260
Methodology: https://510kreport.com/methodology