# K151104: Otelo LL

- Pathway: 510(k) (Traditional)
- Applicant: Spineart
- Decided: Jan 6, 2016 after 257 days
- Product code: GAD (Retractor)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002931 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043602: Quadrant Retractor System, Medtronic Sofamor Danek (2005) Summary page 4.

## Indications for use
The OTELO LL Retractor is intended to provide the surgeon access to the spine by dissection and traction of soft and bony tissue

Source page: https://510kreport.com/device/K151104
Methodology: https://510kreport.com/methodology