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ATEC Lateral Navigation Instruments

Alphatec Spine, Inc.

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

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K223765
Device name
ATEC Lateral Navigation Instruments
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2022-12-15
Decision date
2023-03-23
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 ATEC Lateral Navigation Instruments are intended to facilitate discectomy, boney resection, implant selection, and access during spinal surgery. Navigated instruments are 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. The Stimulating Initial Dilator may also be utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.

Intended Use

The ATEC Lateral Navigation Instruments are intended to facilitate discectomy, boney resection, implant selection, and access during spinal surgery. Navigated instruments are 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. The Stimulating Initial Dilator may also be utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.

Device Description

The ATEC Lateral Navigation Instruments are surgical instruments that are designed to be compatible with Medtronic's StealthStation Surgical Navigation System. The navigated disc preparation and dilator instruments are intended to facilitate discectomy, boney resection, access, and nerve location during spinal surgery. The navigated trials are intended to facilitate implant size selection of Alphatec intervertebral body fusion devices during spinal surgery. All instruments are reusable or single-use and are offered either non-sterile to be cleaned and steam sterilized by the end user or sterile packaged.

Summary parsed at:2026-06-19 05:42:44 UTC

Predicate devices

3

K223765 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 K223765 as a predicate