Manufacturer
Curiteva, Inc.Curiteva Navigation System
Country / Region:United States (US)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K223200
- Device name
- Curiteva Navigation System
- Company
- Curiteva, Inc.
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2022-10-13
- Decision date
- 2023-01-06
- 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 Curiteva Navigation System is intended to be used during the preparation and placement of Curiteva screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Curiteva Navigation System is specifically 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 vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
Intended Use
The Curiteva Navigation System is intended to be used during the preparation and placement of Curiteva screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Curiteva Navigation System is specifically 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 vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
Device Description
The Curiteva Navigation System instruments are reusable surgical instruments for use with the Medtronic® StealthStation® Navigation System S7 v2.1.0 and S8 v1.2.0 (1.2.0-20) to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures for preparation and placement of Curiteva screws. The Curiteva Navigation System includes awls, probes, taps, drills, and drivers. The Curiteva Navigation System instruments are to be used with the Curiteva Pedicle Screw System or the Curiteva Sacroiliac Joint Fusion System, as specified. All instruments are made of stainless steel per ASTM F899. The Curiteva Navigation System instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic StealthStation Navigation System hardware and software.
Summary parsed at:2026-06-19 05:41:05 UTC
Predicate devices
6Cited as predicate
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