# K183276: 7D Surgical System

- Pathway: 510(k) (Special)
- Applicant: 7D Surgical, Inc.
- Decided: Aug 7, 2019 after 257 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K050438 (2005). 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)
- K180352: 7D Surgical System, 7D Surgical, Inc. (2018) Summary page 4.

## Indications for use
The 7D Surgical System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure can be identified.

Source page: https://510kreport.com/device/K183276
Methodology: https://510kreport.com/methodology