Manufacturer
Foundation Surgical Group, Inc.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
Product code
OLO
21 CFR 882.4560
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
