# K896603: HSC Unit Rod

- Pathway: 510(k) (Traditional)
- Applicant: Danek Medical, Inc.
- Decided: Jan 30, 1990 after 70 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.
37 later devices descend from it; 1 cites it directly.
0 of 38 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
- K110676: TSRH Spinal System (2011), 36 descendants of its own
- K120899: Range Spinal System, Unit Rod (2012), 35 descendants of its own
- K131030: Range Spinal System (2013), 34 descendants of its own
- K133944: Range, Spinal System, Everest Spinal System (2014), 33 descendants of its own
- K141873: Range/Mesa/Denali Spinal System (2014), 30 descendants of its own

Source page: https://510kreport.com/device/K896603
Methodology: https://510kreport.com/methodology