Product code OLO· 21 CFR 882.4560
Product code
Predicate devices
Cited as predicate
FDA 510(k) registration fields
The SPINEART Navigation System reusable instruments are intended to be used during the preparation and placement of SPINEART screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART Navigation reusable instruments are specifically designed for use with the Medtronic® StealthStation® System and the Brainlab® Spine & Trauma Navigation System, which are 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 long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
The SPINEART Navigation System reusable instruments are intended to be used during the preparation and placement of SPINEART screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART Navigation reusable instruments are specifically designed for use with the Medtronic® StealthStation® System and the Brainlab® Spine & Trauma Navigation System, which are 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 long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
Summary parsed at:2026-06-19 04:31:06 UTC
No predicate K numbers were extracted
The Summary PDF may not be parsed yet, or this submission may not cite predicate devices
No later 510(k)s cite this device yet
Other submissions will appear here when they list K254158 as a predicate
