FDA.reportPublic FDA data

Stereotactic surgery system probe, single-use

Definition
A slender, rod-like, hand-held manual surgical instrument intended for use during image-guided surgery (e.g., neurosurgical or orthopaedic surgery procedures) to accurately position implantable devices (e.g., shunts), or to correlate the position of its tip with that of a targeted tissue of interest in a patient so the tissue area is precisely identified with respect to diagnostic images stored in the stereotactic surgery system. It is made of metal. This is a single-use device.
GUDID devices
23
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00815212027000NVIEW NAVIGATION TRAY WITH 10 MARKERSIzi Medical Products, LLCNV7412025-10-06
00860012056804Zeta Stylet — SZeta Surgical Inc.ZSS-110 US2026-05-26
00763000738334AxiEM™MEDTRONIC NAVIGATION, INC.97353182026-02-15
00763000738341AxiEM™MEDTRONIC NAVIGATION, INC.97353172026-02-15
00763000738433AxiEM™MEDTRONIC NAVIGATION, INC.97353192026-02-15
00763000738488AxiEM™MEDTRONIC NAVIGATION, INC.97354282026-01-01
00763000738457AxiEM™MEDTRONIC NAVIGATION, INC.9733533XOM2025-03-30
00763000738471AxiEM™MEDTRONIC NAVIGATION, INC.9733534XOM2025-03-30
00815212026812ONPOINT NAVIGATION KITIzi Medical Products, LLCDK02101012024-02-27
00815212026829ONPOINT NAVIGATION TRAYIzi Medical Products, LLCDP02101012024-02-27
00815212026850ONPOINT PEDICLE ACCESS NEEDLEIzi Medical Products, LLCDJ02101012024-02-27
10815212026819ONPOINT NAVIGATION 10 BOXIzi Medical Products, LLCDK02110012024-02-27
20815212026816ONPOINT NAVIGATION 25 BOXESIzi Medical Products, LLCDK02125012024-02-27
03701311501015Navigated Targeting Needle SPX1, Bevel Tip - 11G, 125mmECENTIAL ROBOTICSA010202023-09-04
03701311501053Navigation set SPX1, Targeting Needle SPX1, Bevel Tip - 11G, 125 mmECENTIAL ROBOTICSA010192023-09-04
03701311501077Navigation set SPX1, Targeting Needle SPX1, Trocar Tip - 11G, 125 mmECENTIAL ROBOTICSA010292023-09-04
03596010648136TRIGENSmith & Nephew, Inc.716928032015-08-25
03596010648143TRIGENSmith & Nephew, Inc.716928142015-08-25
03596010648150TRIGENSmith & Nephew, Inc.716928152015-08-25
00850002250220TGSSTRYKER CORPORATIONTGSGW2020-05-19
03701311500056Navigated Targeting Needle SPX1, Bevel Tip - 11G, 125mmECENTIAL ROBOTICSA000202023-03-01
03701311500070Navigation Set SPX1, Targeting Needle Bevel Tip - 11G, 125mmECENTIAL ROBOTICSA000192023-03-01
03701311500421Navigation Set SPX1, Targeting Needle Trocar Tip – 11G, 125mmECENTIAL ROBOTICSA000292023-03-01