# K973454: AD-Tech's Spinal Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Ad-Tech Medical Instrument Corp
- Decided: Jun 10, 1998 after 272 days
- Product code: GZL (Electrode, Depth)
- Device class: 2
- Regulation: 21 CFR 882.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K882053 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882053: Nicolet Epidural Spinal Electrode, Nicolet Instrument Corp. (1988) Summary page 1.

## Indications for use
Ad-Tech’s Spinal Electrode is intended for measurement of muscle MEP (Motor Evoked Potential) type monitoring during spinal surgery.

Source page: https://510kreport.com/device/K973454
Methodology: https://510kreport.com/methodology