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Spine Navigation System

Medivis, Inc.

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

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K233725
Device name
Spine Navigation System
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2023-11-21
Decision date
2024-07-26
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 Spine Navigation system is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. Their use 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 spine, can be identified relative to CT imagery of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the sacro-lumbar region. The headset of the Spine Navigation system displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning. The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.

Intended Use

The Spine Navigation system is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. Their use 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 spine, can be identified relative to CT imagery of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the sacro-lumbar region.

Device Description

The Medivis Spine Navigation System is an image-guided navigation system designed to assist surgeons in placing pedicle screws accurately during spinal surgery. The Medivis Spine Navigation System is comprised of software, a head-mounted display (HMD), passive reflective markers and reusable components. The device provides various image display options and manipulation features, primarily controlled through the touchscreen monitor. An HMD serves as an adjunct display and functions as an optical 3D tracking component for patient and surgical tool localization. The device registers patient data to the surgical environment through IR tracking.

Summary parsed at:2026-06-19 05:29:47 UTC

Predicate devices

1

K233725 references 1 predicate/reference device

Cited as predicate

0

No later 510(k)s cite this device yet

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