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Navigated LLIF Impactable Tracker

Tyber Medical, 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

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K261060
Device name
Navigated LLIF Impactable Tracker
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2026-03-31
Decision date
2026-05-29
Submission type
Traditional
Technology type
Stereotactic Surgery(AI inferred)
Clinical applications
Spine SurgeryNavigation System
Primary application
Spine Surgery
Classification source
AI classified

Indications for Use

The Navigated Instruments are intended to be used during preparation and placement of Medtronic Implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.

The Navigated Instruments are specifically designed for use with the Medtronic StealthStation™ System, 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 a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Intended Use

The Navigated Instruments are intended to be used during preparation and placement of Medtronic Implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Navigated Instruments are specifically designed for use with the Medtronic StealthStation™ System, 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 a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Device Description

The Navigated Instruments are spine preparation instruments made of surgical grade stainless steel per ASTM F899. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. When used with the appropriate Medtronic single-use sterile spheres the subject devices can be used as navigated surgical instruments with the Medtronic Stealth™ Systems (Medtronic computer-assisted surgery system) to track the instruments in the surgical field. Specialized cases and trays are available for optional use with the Navigated Instruments. They are manufactured from stainless steel per ASTM F899, aluminum per ASTM B209, and silicone. Ancillary instrumentation is available for optional use with the Navigated Instruments. These instruments are not specifically intended to be used with the subject device. The Navigated Instruments are provided non-sterile.

Summary parsed at:2026-06-19 04:32:23 UTC

Predicate devices

2

K261060 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K261060 as a predicate