Atlas FDA

KNEE MODULE FOR THE STEALTHSTATION SYSTEM

FDA 510(k) clearance K012937 · decided 2002-01-25

Clearance details

K-number
K012937
Device name
KNEE MODULE FOR THE STEALTHSTATION SYSTEM
Applicant
Medtronic Surgical Navigation Technologies
Decision
Substantially Equivalent
Date received
2001-08-31
Decision date
2002-01-25
Days to decision
147 days
Clearance type
Traditional
Product code
HAW
Device class
2
Regulation number
882.4560
Medical specialty
Neurology
Advisory committee
Neurology
Location
Louisville, CO, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Medtronic Surgical Navigation Technologies

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Leksell® Vantage Stereotactic System (K261932)Elekta Solutions AB2026-08-05
Zeta Navigation System (K253663)Zeta Surgical, Inc.2026-05-01
Stealth AXiS Cranial clinical application (K253379)Medtronic Navigation, Inc.2026-03-26
NeuroAlign software (K231897)Medivis, Inc.2025-10-21
SOLOPASS 2.0 System (K251317)Intravent Medical Partners2025-09-05
Ball Joint Guide Array (66295) (K250893)Bayer Medical Care, Inc.2025-09-04
EZ-FIDUCIALS (K250505)Phasor Health, LLC2025-07-09
Stereotaxic Guiding Surgical Devices, NaoTrac S (K242575)Brain Navi Biotechnology Co., Ltd.2025-05-23
Navient Image Guide Navigation System (955-NC-NC), Cranial (K241327)Claronav2025-02-05
Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT (K243698)Brainlab AG2025-01-28
ClearPoint System (Software Version 3.0) (K243657)ClearPoint Neuro, Inc.2025-01-24
Geniant Cranial (Navigated Neurosurgical Positioning Robot) (K241333)Koh Young Technology, Inc.2025-01-17

Recalls involving this device

RecordFirmDate
BAG 9732315 MOUSE STERILE 15 PK recall (Z-1578-2014)Medtronic Navigation, Inc.2014-05-09
BIOPSY NEEDLE KIT, 9733068, PASSIVE recall (Z-1579-2014)Medtronic Navigation, Inc.2014-05-09
BIT 9733516 2.9mm DRILL STERILE recall (Z-1580-2014)Medtronic Navigation, Inc.2014-05-09
DISP 9730950 STRL SPHERE, 1 PK INSERT recall (Z-1581-2014)Medtronic Navigation, Inc.2014-05-09
DISP 9730951 STRL SPHERE, 5PK INSERT recall (Z-1582-2014)Medtronic Navigation, Inc.2014-05-09
DRAPE 9732722 TUBE STERILE O-ARM 20PK recall (Z-1583-2014)Medtronic Navigation, Inc.2014-05-09
ENT PRGM 9734636 ADD FUSION NAV AxiEM recall (Z-1584-2014)Medtronic Navigation, Inc.2014-05-09
INST 9731132 KIT CR REF FRAME DRIVER 5PK recall (Z-1585-2014)Medtronic Navigation, Inc.2014-05-09
INSTRUMENT TRACKER 9733533XOM ENT 1PK recall (Z-1586-2014)Medtronic Navigation, Inc.2014-05-09
KIT, 9731427, THORACIC TACTILE PROBES recall (Z-1587-2014)Medtronic Navigation, Inc.2014-05-09
MOUSE 9732721 STERILE O-ARM 10PK recall (Z-1588-2014)Medtronic Navigation, Inc.2014-05-09
PACK 9731975 TUMOR RESECTION AXIEM CR recall (Z-1589-2014)Medtronic Navigation, Inc.2014-05-09
PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT recall (Z-1590-2014)Medtronic Navigation, Inc.2014-05-09
PATIENT TRACKER 9733534XOM ENT 1PK recall (Z-1591-2014)Medtronic Navigation, Inc.2014-05-09
PIN, 9733235, 100MM, STERILE, PERC REF recall (Z-1592-2014)Medtronic Navigation, Inc.2014-05-09
PIN, 9733236, 150MM, STERILE, PERC REF recall (Z-1593-2014)Medtronic Navigation, Inc.2014-05-09
SHUNT KIT 9733605 NON-INVASIVE recall (Z-1594-2014)Medtronic Navigation, Inc.2014-05-09
SPHERES 8801071 1/TRAY 12PK recall (Z-1595-2014)Medtronic Navigation, Inc.2014-05-09
SPHERES 8801075 5/TRAY 12PK recall (Z-1596-2014)Medtronic Navigation, Inc.2014-05-09
TRAJ GUIDE KIT, 9733065, BIOPSY, EXT recall (Z-1597-2014)Medtronic Navigation, Inc.2014-05-09
TRAJ GUIDE KIT, 9733066, BIOPSY, INT recall (Z-1598-2014)Medtronic Navigation, Inc.2014-05-09
TUMOR RES. PACK 9733553 AxiEM S.M. recall (Z-1599-2014)Medtronic Navigation, Inc.2014-05-09
TUMOR RESECTION KIT 9733607 NON-INVASIVE recall (Z-1600-2014)Medtronic Navigation, Inc.2014-05-09
TUMOR RESECTION KIT 9733608 SKULL MOUNT recall (Z-1601-2014)Medtronic Navigation, Inc.2014-05-09
UPGRD PRGM 9734638 ADD AxiEM NAVIGATION recall (Z-1602-2014)Medtronic Navigation, Inc.2014-05-09
Fix pins associated with Stealth Station Treatment Guidance Platform recall (Z-0231-04)Medtronic Surgical Navigation Tech, Inc2003-12-17