# K180816: Ziehm RFD 3D Tracker

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation
- Decided: Jul 11, 2018 after 104 days
- Product code: OLO (Orthopedic 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: 1 generation back to K022414 (2002). 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)
- K022414: Stealthstation System Three Dimensional C-Arm Interface, Medtronic Surgical Navigation Technologies (2002) Summary page 5.

## Indications for use
The Ziehm RFD 3D Interface is an accessory to the StealthStation System. It is intended to be used with the Ziehm Vision RFD 3D C-arm to automatically transfer to and register three dimensional images on the StealthStation System for use in image-guided spinal surgery.

Source page: https://510kreport.com/device/K180816
Methodology: https://510kreport.com/methodology