# K031510: Nim-Spine

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed
- Decided: Jun 18, 2003 after 35 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). 11 ancestors in all.
40 later devices descend from it; 4 cite it directly.
1 of 52 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923315: Nicolet Ark System, Nicolet Instrument Corp. (1992) Summary page 2.
- K890495: Nicolet Viking II System, Nicolet Instrument Corp. (1989) Summary page 2.
- K880573: Modified Nicolet Viking System, Nicolet Biomedical Instruments (1988) Summary page 2.
- K842956: Nicolet Viking, Nicolet Biomedical Instruments (1984) Summary page 2.
- K991054: Bravo Multi-Modality System, Nicolet Biomedical, Inc. (1999) Summary page 2.
- K014165: Stimulus - Dissection Instruments, Medtronic Xomed, Inc. (2002)
- (no number) Neurosign 800: named in the summary without a submission number

## Most influential descendants
- K083124: NIM 3.0 (2009), 30 descendants of its own
- K182542: The EPAD 2 System (2019), 9 descendants of its own
- K162313: NuVasive Next Generation NVM5 System (2017), 7 descendants of its own
- K162199: Cascade IOMAX Intraoperative Monitor (2017), 7 descendants of its own
- K100992: Neuralmas (2010), 6 descendants of its own

## Indications for use
This device is intended for use in surgical procedures for patient-connected intraoperative nerve monitoring, i.e. assisting the surgeon in locating and mapping motor nerves through the use of electromyographic (EMG) signals and electrical stimulus of nerves. This device is indicated for locating and identifying cranial and peripheral motor nerves during surgery, including spinal nerve roots.

Source page: https://510kreport.com/device/K031510
Methodology: https://510kreport.com/methodology