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Ion-C Navigation Instruments

SurGenTec, LLC

Country / Region:United States (US)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

United States (US)

Product code

OLO
21 CFR 882.4560

Predicate devices

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K260329
Device name
Ion-C Navigation Instruments
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2026-01-30
Decision date
2026-05-22
Submission type
Traditional
Technology type
Image Guided Surgery(AI inferred)
Clinical applications
Spine SurgeryNavigation System
Primary application
Spine Surgery
Classification source
AI classified

Indications for Use

The ION-C Navigation Instruments are intended to be used with the ION-C System Facet Implants during spinal surgery to assist the surgeon in precisely locating anatomical structures, specifically the cervical facet joint, in either open or minimally invasive procedures. These instruments are specifically designed for use with the Medtronic StealthStation System S8, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy. Fluoroscopy must be used to confirm final implant placement.

Intended Use

The ION-C Navigation Instruments are intended to be used with the ION-C System Facet Implants during spinal surgery to assist the surgeon in precisely locating anatomical structures, specifically the cervical facet joint, in either open or minimally invasive procedures. These instruments are specifically designed for use with the Medtronic StealthStation System S8, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy. Fluoroscopy must be used to confirm final implant placement.

Device Description

The Ion-C Navigation Instruments include locators, a drill, and an inserter. Each Instrument is intended to be used with the Medtronic NavLock Array. The Ion-C Navigation Instruments are provided sterile or non-sterile and are used during the surgical procedure to implant Ion-C System Facet Implants. Specifically, the Ion-C Navigation Instruments are intended to assist the surgeon in locating anatomical structures, specifically the cervical facet joint, in either open or minimally invasive procedures. The Ion-C Navigation Instruments are intended to be used with StealthStation S8.

Summary parsed at:2026-06-19 04:31:56 UTC

Predicate devices

3

K260329 references 3 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K260329 as a predicate