# K180092: Intellitorq

- Pathway: 510(k) (Traditional)
- Applicant: Gauthier Biomedical, Inc.
- Decided: Mar 8, 2018 after 55 days
- Product code: HXC (Wrench)
- Device class: 1
- Regulation: 21 CFR 888.4540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The device is intended to indicate the applied torque according to the set target torque value. This device is intended for use in surgical procedures on bone and tissue by a surgeon trained in its intended use.

Source page: https://510kreport.com/device/K180092
Methodology: https://510kreport.com/methodology