Manufacturer
Innovasis, Inc.Excella Navigation Instruments
Country / Region:United States (US)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Predicate devices
0
Cited in this 510(k)
Device details
FDA 510(k) registration fields
- K number
- K223511
- Device name
- Excella Navigation Instruments
- Company
- Innovasis, Inc.
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2022-11-22
- Decision date
- 2023-05-02
- 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 Excella® Navigation Instruments are intended to be used during the preparation and placement of Excella II®, Excella 3® & Excella MIS® screws during spinal surgery to assist the surgeon in locating anatomical structures in either open or percutaneous spinal procedures. The Excella Navigation Instruments are specifically designed for use with the Medtronic® StealthStation® System SB and associated tracking arrays, 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 an acquired image (CT, MR, 2D/3D fluoroscopic image reconstruction) and/or an image-based model of the anatomy.
Intended Use
The Excella® Navigation Instruments are intended to be used during the preparation and placement of Excella II®, Excella 3® & Excella MIS® screws during spinal surgery to assist the surgeon in locating anatomical structures in either open or percutaneous spinal procedures. The Excella Navigation Instruments are specifically designed for use with the Medtronic® StealthStation® System SB and associated tracking arrays, 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 an acquired image (CT, MR, 2D/3D fluoroscopic image reconstruction) and/or an image-based model of the anatomy.
Device Description
The Innovasis® Excella® Navigation Instruments are reusable instruments used for the preparation and insertion of Excella III, Excella 3® & Excella MIS® screws, in either open or percutaneous procedures. These instruments are designed for navigated use with the Medtronic® StealthStation® System or as standalone, unnavigated instruments.
Summary parsed at:2026-06-19 05:41:49 UTC
Predicate devices
0No predicate K numbers were extracted
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Cited as predicate
1Innovasis Navigation Instruments
1 submission cite K223511 as a predicate