Manufacturer
SurGenTec, LLCIon-C Navigation Instruments
Country / Region:United States (US)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K260329
- Device name
- Ion-C Navigation Instruments
- Company
- SurGenTec, LLC
- 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
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Not ingested
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Not ingested
CORUS Navigation Access System
K260329 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K260329 as a predicate
