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NEXXT SPINE NAVIGATION System

Nexxt Spine, 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

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K220291
Device name
NEXXT SPINE NAVIGATION System
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2022-02-01
Decision date
2022-03-31
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 NEXXT SPINE NAVIGATION System is an instrumentation system intended to be used during preparation and placement of Nexxt Spine's INERTIA® Systems pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are 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 NEXXT SPINE NAVIGATION System is an instrumentation system intended to be used during preparation and placement of Nexxt Spine's INERTIA® Systems pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are 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 NEXXT SPINE NAVIGATION System is an instrumentation system which includes taps and a probe, an awl and an inserter. The devices are used in conjunction with the Medtronic® StealthStation Navigation System to assist with placement of the Nexxt Spine INERTIA® Systems pedicle screws. The instruments are sold non-sterile and are reusable.

Summary parsed at:2026-06-24 04:32:10 UTC

Predicate devices

1

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