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VADER® Pedicle System Navigated Instruments

Icotec AG

Country / Region:Switzerland (CH)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

Switzerland (CH)

Product code

OLO
21 CFR 882.4560

Predicate devices

5

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K230861
Device name
VADER® Pedicle System Navigated Instruments
Company
Icotec AG
Country / Region
Switzerland(CH)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2023-03-29
Decision date
2023-06-27
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

icotec Navigation Instruments are intended to be used during the preparation and placement of FDA-cleared icotec pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. These instruments are designed for use with stereotactic navigation system Medtronic StealthStation®, 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

icotec Navigation Instruments are intended to be used during the preparation and placement of FDA-cleared icotec pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. These instruments are designed for use with stereotactic navigation system Medtronic StealthStation®, 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

icotec's VADER® Pedicle System Navigated Instruments are reusable instruments used for the preparation and placement of FDA-cleared icotec pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. These instruments are designed for use with navigation system Medtronic StealthStation®, in combination with the Medtronic NavLock™ tracker and Medtronic SureTrak®II clamps and arrays. The VADER® Pedicle System Navigated Instruments include awls, probes, taps, drivers and adapters. The VADER® Pedicle System Navigated Instruments are to be used with the FDA-cleared icotec pedicle screws cleared under K222789, K200596, K193423 and K190545.

Summary parsed at:2026-06-19 05:45:38 UTC

Predicate devices

5

K230861 references 5 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K230861 as a predicate