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Kalitec Navigated Instrument System

Kalitec Direct, LLC Doing Business AS Kalitec Medical

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

Product code OLO· 21 CFR 882.4560

Summary PDF

Product code

OLO
21 CFR 882.4560

Predicate devices

4

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K232572
Device name
Kalitec Navigated Instrument System
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2023-08-24
Decision date
2023-12-13
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 Kalitec Navigated Instrument System is indicated for use during the preparation and placement of screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Kalitec Navigated Instruments System reusable instruments are specifically designed for use with the Medtronic Navigation StealthStation System which are 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 for the anatomy. Use of the Kalitec Navigated Instrument System instruments is limited to use only with Kalitec pedicle screw systems.

Intended Use

The Kalitec Navigated Instrument System is indicated for use during the preparation and placement of screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Kalitec Navigated Instruments System reusable instruments are specifically designed for use with the Medtronic Navigation StealthStation System which are 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 for the anatomy. Use of the Kalitec Navigated Instrument System instruments is limited to use only with Kalitec pedicle screw systems.

Device Description

The Kalitec Navigated Instrument System is comprised of nonsterile, reusable instruments, including probes, taps, and drivers that can be operated manually. These instruments are designed to function with the Medtronic StealthStation® $8(v2.0.1-7) System, in combination with the Medtronic NavLock™ tracker and Medtronic SureTrak®ll clamps and arrays to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures for preparation and placement of Kalitec polyaxial screws.

Summary parsed at:2026-06-19 05:50:29 UTC

Predicate devices

4

K232572 references 4 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K232572 as a predicate