# K082032: Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models 3308, 3309, 3310)

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Spine, Inc.
- Decided: Oct 6, 2008 after 81 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
29 later devices descend from it; 8 cite it directly.
0 of 30 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
- K131980: Sequoia Pedicle Screw System Including Speedlink II Transverse Connector System (2013), 10 descendants of its own
- K203507: Vitality® Spinal Fixation System (2021), 8 descendants of its own
- K101682: S 100 Pedicle Screw System (2010), 8 descendants of its own
- K162764: Jazz Frame System (2017), 6 descendants of its own
- K230116: Vital™ Spinal Fixation System (2023), 5 descendants of its own

## Recalls of this device
- Aug 20, 2009 · Not classified · Z-0554-2010: The tip of the instrument may fracture during use.

Source page: https://510kreport.com/device/K082032
Methodology: https://510kreport.com/methodology