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Foundation Surgical Navigated Lateral Disc Prep Instruments

Foundation Surgical Group, 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
K260011
Device name
Foundation Surgical Navigated Lateral Disc Prep Instruments
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2026-01-02
Decision date
2026-04-16
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

Foundation Surgical Navigated Lateral Disc Prep Instruments are intended to be used during preparation of the intervertebral disc space during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.

Foundation Surgical Navigated Lateral Disc Prep Instruments are specifically designed for use with the Medtronic StealthStation™ S8 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 a vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses as described on the label and the instruments.

The Navigated Trials are intended to be used to facilitate implant size selection of matching implants during spinal surgery.

Intended Use

Foundation Surgical Navigated Lateral Disc Prep Instruments are intended to be used during preparation of the intervertebral disc space during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Foundation Surgical Navigated Lateral Disc Prep Instruments are specifically designed for use with the Medtronic StealthStation™ S8 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 a vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

Device Description

The Foundation Surgical Navigated Lateral Disc Prep Instruments are orthopedic stereotaxic instruments designed for use in procedures where the use of stereotactic surgery may be appropriate. The instruments are compatible with Medtronic NavLock Trackers and Medtronic single-use sterile spheres to allow computer-assisted surgery with the StealthStation S8 system to track the instruments in the surgical field. The Foundation Surgical Navigated Lateral Disc Prep Instruments are manufactured from medical grade stainless steel per ASTM F899 and include trials, dilators, awls, taps, shavers, cobbs, and osteotomes for disc preparation for the placement of the Interwedge® Lateral Interbody Fusion (LIF) system into the treated disc space.

Summary parsed at:2026-06-19 04:31:26 UTC

Predicate devices

3

K260011 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 K260011 as a predicate