FDA 510(k) Applications Submitted by MEDTRONIC NAVIGATION, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K153660 |
12/21/2015 |
StealthStation System with Cranial Software |
MEDTRONIC NAVIGATION, INC. |
| K153555 |
12/14/2015 |
EM ENT Navigated Suctions |
MEDTRONIC NAVIGATION, INC. |
| K133665 |
11/29/2013 |
MALLEABLE SUCTION INSTRUMENTS |
MEDTRONIC NAVIGATION, INC. |
| K141833 |
07/07/2014 |
STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION |
MEDTRONIC NAVIGATION, INC. |
| K162604 |
09/19/2016 |
Cranial Reducing Tubes |
MEDTRONIC NAVIGATION, INC. |
| K201189 |
05/01/2020 |
Stealthstation S8 Spine Software v1.3.0 |
Medtronic Navigation, Inc. |
| K191597 |
06/17/2019 |
Stealth Autoguide System, Midas Rex Legend Depth Stop System |
Medtronic Navigation, Inc. |
| K170018 |
01/03/2017 |
StealthStationTM S8 ENT Software |
Medtronic Navigation, Inc. |
| K133444 |
11/12/2013 |
STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM |
MEDTRONIC NAVIGATION, INC. |
| K150216 |
01/30/2015 |
Synergy Cranial |
MEDTRONIC NAVIGATION, INC. |
| K081512 |
05/30/2008 |
STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE |
MEDTRONIC NAVIGATION, INC. |
| K124004 |
12/26/2012 |
NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS |
MEDTRONIC NAVIGATION, INC. |
| K162655 |
09/23/2016 |
StealthConnect Remote Viewing, Planning and Collaboration System |
MEDTRONIC NAVIGATION, INC. |
| K131425 |
05/17/2013 |
NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER |
MEDTRONIC NAVIGATION, INC. |
| K153247 |
11/09/2015 |
Fusion Compact Navigation System |
MEDTRONIC NAVIGATION, INC. |
| K130608 |
03/07/2013 |
QUADCUT |
MEDTRONIC NAVIGATION, INC. |
| K211269 |
04/27/2021 |
Visualase MRI-Guided Laser Ablation System (SW 3.4) |
Medtronic Navigation, Inc. |
| K221087 |
04/13/2022 |
Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 |
Medtronic Navigation, Inc. |
| K203639 |
12/14/2020 |
StealthStation Cranial Software v1.3.2 |
Medtronic Navigation, Inc. |
| K162309 |
08/17/2016 |
StealthStation S8 System Platforms and StealthStation Cranial Software |
MEDTRONIC NAVIGATION, INC. |
| K050651 |
03/14/2005 |
MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION |
MEDTRONIC NAVIGATION, INC. |
| K061248 |
05/03/2006 |
AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM |
MEDTRONIC NAVIGATION, INC. |
| K052623 |
09/23/2005 |
IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM |
MEDTRONIC NAVIGATION, INC. |
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