# K001037: Modification to Ebi Spinelink System

- Pathway: 510(k) (Special)
- Applicant: Ebi, L.P.
- Decided: Apr 14, 2000 after 14 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K063637: Reliance VBS System (2007), 1 descendant of its own
- K081383: Reliance VBS System (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K001037
Methodology: https://510kreport.com/methodology