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Zavation Navigation Instrument System

Zavation Medical Products, 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

4

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K223808
Device name
Zavation Navigation Instrument System
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2022-12-20
Decision date
2023-07-12
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

Zavation Navigated Instrument System are indicated for use during the placement of Zavation Spine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Zavation Navigated Instruments are reusable and 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 Zavation Navigated Instrument System is limited to use only with Zavation Spinal System and Zavation Z-LinkPC System.

Intended Use

Zavation Navigated Instrument System are indicated for use during the placement of Zavation Spine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Zavation Navigated Instruments are reusable and 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 Zavation Navigated Instrument System is limited to use only with Zavation Spinal System and Zavation Z-LinkPC System.

Device Description

The Zavation Navigation instruments are non-sterile, reusable instruments that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation® System to aid in implantation of associated Zavation screw implants. The instruments are manufactured from stainless steel per ASTM F899.

Summary parsed at:2026-06-19 05:43:12 UTC

Predicate devices

4

K223808 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 K223808 as a predicate