|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
stealthstation cranial software, v3.1.5 (9735585)
|
Medtronic Navigation, Inc.
|
K231976 |
10/19/2023
|
synergy cranial v2.2.9, stealthstation cranial v3.1.4
|
Medtronic Navigation, Inc.
|
K221087 |
06/10/2022
|
stealthstation cranial software v1.3.2
|
Medtronic Navigation, Inc.
|
K203639 |
01/13/2021
|
stealth autoguide system, midas rex legend depth stop system
|
Medtronic Navigation, Inc.
|
K191597 |
11/01/2019
|
stealthconnect remote viewing, planning and collaboration system
|
MEDTRONIC NAVIGATION, INC.
|
K162655 |
04/21/2017
|
stealthstation s8 system platforms and stealthstation cranial software
|
MEDTRONIC NAVIGATION, INC.
|
K162309 |
03/31/2017
|
cranial reducing tubes
|
MEDTRONIC NAVIGATION, INC.
|
K162604 |
12/30/2016
|
stealthstation system with cranial software
|
MEDTRONIC NAVIGATION, INC.
|
K153660 |
09/14/2016
|
synergy cranial
|
MEDTRONIC NAVIGATION, INC.
|
K150216 |
06/11/2015
|
stylet, 23cm, skull-mount patient tracker, non-invasive patient tracker, tracer pointer, touch-n-go pointer, navigation
|
MEDTRONIC NAVIGATION, INC.
|
K141833 |
03/25/2015
|