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CoreLink Navigation Instruments

Corelink, LLC

Country / Region:United States (US)Submission type:Special

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

United States (US)

Product code

OLO
21 CFR 882.4560

Predicate devices

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K214059
Device name
CoreLink Navigation Instruments
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2021-12-27
Decision date
2022-01-19
Submission type
Special
Technology type
Stereotactic Surgery(AI inferred)
Clinical applications
Spine SurgeryNavigation System
Primary application
Spine Surgery
Classification source
AI classified

Indications for Use

CoreLink Navigation Instruments are intended to be used in the preparation and placement of Tiger OCT screw implants 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 S8 (V1.2.20), 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

CoreLink Navigation Instruments are intended to be used in the preparation and placement of Tiger OCT screw implants 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 S8 (V1.2.20), 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

CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures. The purpose of this submission is to add instruments to the previously cleared CoreLink Navigation Instruments set to offer compatibility with CoreLink OCT pedicle screws.

Summary parsed at:2026-06-24 04:19:09 UTC

Predicate devices

3

K214059 references 3 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K214059 as a predicate