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INNOVERSE Navigation Instruments

Innosys Co., Ltd.

Country / Region:Korea, Republic of (KR)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

Korea, Republic of (KR)

Product code

OLO
21 CFR 882.4560

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K241082
Device name
INNOVERSE Navigation Instruments
Country / Region
Korea, Republic of(KR)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2024-04-19
Decision date
2024-06-14
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

INNOVERSE Navigation Instruments are intended to be used during the preparation and placement of INNOVERSE Spinal System implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in spinal procedures. These instruments are designed for use with the stereotactic navigation system Medtronic® StealthStation™, 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

INNOVERSE Navigation Instruments are intended to be used during the preparation and placement of INNOVERSE Spinal System implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in spinal procedures. These instruments are designed for use with the stereotactic navigation system Medtronic® StealthStation™, 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 INNOVERSE Navigation Instruments are reusable surgical instruments for use with the Medtronic® StealthStation™ Navigation System to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures for preparation and placement of pedicle screw implants. The INNOVERSE Navigation Instruments include awls, probes, taps, and drivers and are to be used with the INNOVERSE Spinal System. All instruments are made from Stainless Steel per ASTM F899. The INNOVERSE Navigation 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 05:32:54 UTC

Predicate devices

2

K241082 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

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