ClearanceBrief
510(k) K990214 ยท HAW Neurological Stereotaxic Instrument

FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM

ApplicantSurgical Navigation Technologies, Inc., Broomfield CO, US
DecisionSubstantially Equivalent, Apr 22, 1999
ReceivedJan 22, 1999
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K990214

DateFirm and productCodeLinked 510(k)
May 9, 2014Medtronic Navigation, Inc.
BAG 9732315 MOUSE STERILE 15 PK
Terminated		 HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
BIOPSY NEEDLE KIT, 9733068, PASSIVE
Terminated		 HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
BIT 9733516 2.9mm DRILL STERILE
Terminated		 HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
DISP 9730950 STRL SPHERE, 1 PK INSERT
Terminated		 HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
DISP 9730951 STRL SPHERE, 5PK INSERT
Terminated		 HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
DRAPE 9732722 TUBE STERILE O-ARM 20PK
Terminated		 GXYNone listed
May 9, 2014Medtronic Navigation, Inc.
ENT PRGM 9734636 ADD FUSION NAV AxiEM
Terminated		 HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
INST 9731132 KIT CR REF FRAME DRIVER 5PK
Terminated		 HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
INSTRUMENT TRACKER 9733533XOM ENT 1PK
Terminated		 HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
KIT, 9731427, THORACIC TACTILE PROBES
Terminated		 HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
MOUSE 9732721 STERILE O-ARM 10PK
Terminated		 GXYNone listed
May 9, 2014Medtronic Navigation, Inc.
PACK 9731975 TUMOR RESECTION AXIEM CR
Terminated		 HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
Terminated		 HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
PATIENT TRACKER 9733534XOM ENT 1PK
Terminated		 HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
PIN, 9733235, 100MM, STERILE, PERC REF
Terminated		 HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
PIN, 9733236, 150MM, STERILE, PERC REF
Terminated		 HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
SHUNT KIT 9733605 NON-INVASIVE
Terminated		 HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
SPHERES 8801071 1/TRAY 12PK
Terminated		 HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
SPHERES 8801075 5/TRAY 12PK
Terminated		 HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
Terminated		 HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
TRAJ GUIDE KIT, 9733066, BIOPSY, INT
Terminated		 HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
TUMOR RES. PACK 9733553 AxiEM S.M.
Terminated		 HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
TUMOR RESECTION KIT 9733607 NON-INVASIVE
Terminated		 HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
TUMOR RESECTION KIT 9733608 SKULL MOUNT
Terminated		 HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
Terminated		 HAWNone listed
Mar 8, 2012Medtronic Navigation, Inc.
Left Long Tactile Probe, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used
Terminated		 HAWNone listed
Mar 8, 2012Medtronic Navigation, Inc.
Right Long Tactile Probe, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable handheld instruments used in spine surgeries for preparation of the pedicle. These instruments are used
Terminated		 HAWNone listed
Oct 3, 2011Medtronic Navigation, Inc
Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments
Terminated		 HAWNone listed
Oct 3, 2011Medtronic Navigation, Inc
Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instrument
Terminated		 HAWNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.