# K111671: Seaspine Monopolar Probe Sysyem

- Pathway: 510(k) (Traditional)
- Applicant: Seaspine, Inc.
- Decided: Dec 28, 2011 after 196 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K980148 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014165: Stimulus - Dissection Instruments, Medtronic Xomed, Inc. (2002) Summary page 1.
- K051718: Nuvasive Neurovision JJB System, Nuvasive, Inc. (2005) Summary page 1.

## Indications for use
The SeaSpine Monopolar Probe System is indicated for tissue dilation and nervous tissue stimulation by means of electrical current to assess location and identification of motor nerves (including spinal nerve roots) for nervous tissue avoidance during a routine surgical approach to the spine.

Source page: https://510kreport.com/device/K111671
Methodology: https://510kreport.com/methodology