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DeGen Navigated Instrumentation

Degen Medical

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

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K213918
Device name
DeGen Navigated Instrumentation
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2021-12-15
Decision date
2022-02-09
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

The DeGen Medical Navigated Instrumentation is intended to be used during the preparation and placement of DeGen Medical F1 MPS and E3 MIS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. DeGen Medical Navigated Instrumentation 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 DeGen Medical Navigated Instrumentation is intended to be used during the preparation and placement of DeGen Medical F1 MPS and E3 MIS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. DeGen Medical Navigated Instrumentation 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 DeGen Navigated Instrumentation is nonsterile, reusable drivers that are intended to be used with the Medtronic StealthStation® Application 1.2.0 (1.2.0-20) and are manufactured from stainless steel per ASTM F899.

Summary parsed at:2026-06-24 04:17:57 UTC

Predicate devices

2

K213918 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K213918 as a predicate