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Medyssey Navigation System

Medyssey Co, Ltd.

Country / Region:Korea, Republic of (KR)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

Korea, Republic of (KR)

Product code

OLO
21 CFR 882.4560

Predicate devices

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K242806
Device name
Medyssey Navigation System
Country / Region
Korea, Republic of(KR)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2024-09-17
Decision date
2025-04-16
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 Medyssey Navigation System is indicated for use during the preparation and placement of Medyssey screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Medyssey Navigation System is reusable and is specifically designed for use with the Medtronic Navigation 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 for the anatomy. Use of the Medyssey Navigation System is limited to use only with ILIAD™ Spinal Fixation System and Zenius™ Spinal Fixation System (including Hedjet and ARTeMIS pedicle screw systems).

Intended Use

The Medyssey Navigation System is indicated for use during the preparation and placement of Medyssey screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Medyssey Navigation System is reusable and is specifically designed for use with the Medtronic Navigation 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 for the anatomy. Use of the Medyssey Navigation System is limited to use only with ILIAD™ Spinal Fixation System and Zenius™ Spinal Fixation System (including Hedjet and ARTeMIS pedicle screw systems).

Device Description

Medyssey Navigation System is comprised of reusable instruments intended to be used in conjunction with the Medtronic StealthStation® Navigation System and its associated NavLock arrays to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. The Medyssey Navigation System is comprised of Bone Taps and Screw Drivers. These instruments are made of medical grade stainless steel. The Medyssey Navigation System is supplied clean and non-sterile, to be sterilized by the end user.

Summary parsed at:2026-06-19 05:18:03 UTC

Predicate devices

3

K242806 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 K242806 as a predicate