# K011508: CD Horizon Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Jun 12, 2001 after 27 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
714 later devices descend from it; 2 cite it directly.
1 of 715 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
- K041460: CD Horizon Spinal System (2004), 712 descendants of its own
- K042167: Modification to: CD Horizon Spinal System (2004), 658 descendants of its own
- K091974: Modification to CD Horizon Spinal System (2009), 656 descendants of its own
- K102555: CD Horizon Spinal System (2010), 598 descendants of its own
- K112473: CD Horizon Spinal System (2011), 597 descendants of its own

Source page: https://510kreport.com/device/K011508
Methodology: https://510kreport.com/methodology