# K000094: Modification to CD Horizon Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Feb 8, 2000 after 26 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal 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.
988 later devices descend from it; 3 cite it directly.
1 of 989 devices in its family (counting itself) has 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
- K042025: Modification to CD Horizon Spinal System (2004), 987 descendants of its own
- K043151: Modification to: CD Horizon Spinal System (2005), 880 descendants of its own
- K050809: CD Horizon Spinal System (2005), 870 descendants of its own
- K060615: CD Horizon Spinal System (2006), 822 descendants of its own
- K063670: Modifications to CD Horizon Spinal System (2007), 821 descendants of its own

Source page: https://510kreport.com/device/K000094
Methodology: https://510kreport.com/methodology