Neurological Stereotaxic Instrument
FDA product code HAW · 410 cleared devices
Class 2
Neurology
- Regulation
- 21 CFR 882.4560
- Review panel
- NE
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1979-04-05 – 2026-09-10
HAW
2011-04-28
HAW
2011-02-07
NAVIGATION MARKER, REFLECTIVE MARKER SPHERES
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HAW
2010-09-23
ROSA SURGICAL DEVICE
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HAW
2010-08-26
TENZING SYSTEM
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HAW
2010-07-14
DISPOSABLE REFLECTIVE MARKER SPHERES
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HAW
2010-05-06
VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED
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HAW
2010-03-31
IMNS MEDACTA NAVIGATION SYSTEM,33.221000US
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HAW
2010-02-12
WAYPOINT STEREOTACTIC SYSTEM
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HAW
2009-11-17
ROSA SURGICAL DEVICE, MODEL ROSA 1.1
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HAW
2009-10-09
WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM
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HAW
2009-09-25
SONOWAND INVITE
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HAW
2009-09-18
MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS
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HAW
2009-08-06
MONTERIS MEDICAL UFO
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HAW
2009-05-08
CRANIAL IMAGE GUIDED SURGERY SYSTEM
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HAW
2009-05-01
LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS
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HAW
2009-02-20
PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0
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HAW
2008-11-25
MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0
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HAW
2008-10-29
PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1
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HAW
2008-09-05
BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED
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HAW
2008-08-06
TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES
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HAW
2008-07-18
PIGALILEO 4TH GENERATION SYSTEM
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HAW
2008-07-17
STRYKER POWER TOOL NAVIGATOR ATTACHMENT
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HAW
2008-06-06
UNI-KNEE 2.0
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HAW
2008-05-23
ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106
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HAW
2008-05-23
SPINEASSIST SYSTEM
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HAW
2008-05-13
LEKSELL SURGIPLAN, MODEL 1006947
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HAW
2008-02-06
ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0
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HAW
2008-01-24
MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)
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HAW
2007-12-18
STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE
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HAW
2007-12-10
TOTAL HIP SURGETICS NAVIGATION SYSTEM
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HAW
2007-10-12
VECTOR VISION HIP
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HAW
2007-10-11
VECTORVISION HIP AND HIP SR
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HAW
2007-09-25
BRAINSUITE NET
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HAW
2007-09-19
NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL
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HAW
2007-08-23
SPINEASSIST SYSTEM
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HAW
2007-07-31
PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM
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HAW
2007-07-20
NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003
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HAW
2007-07-02
DEPUY CAS HEMI ASR HIP INSTRUMENTS
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HAW
2007-05-23
DEPUY CI HIP INSTRUMENTATION
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HAW
2007-04-23
VV FLUORO 3D
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HAW
2007-04-05
ARGOS
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HAW
2007-02-28
CTLOGICS NAVIGATIONS SYSTEMS
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HAW
2007-01-17
MODIFICATION TO VECTORVISION TRAUMA
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HAW
2006-12-14
STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000
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HAW
2006-12-12
VECTORVISION HIP SR
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HAW
2006-11-08
ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION
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HAW
2006-10-06
PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM
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HAW
2006-09-20
NAVIVISION
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HAW
2006-09-05
LAPDOC I
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HAW
2006-08-31
AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
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HAW
2006-08-21
UNI KNEE SURGETICS NAVIGATION SYSTEM
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HAW
2006-08-21
VECTORVISION HIP
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HAW
2006-08-04
STRYKER ORTHOPAEDICS RFID INSTRUMENTATION
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HAW
2006-07-31
BRIGIT SURGICAL DEVICE
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HAW
2006-07-25
BRAINPRO, BRAINPRO ACCESS
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HAW
2006-06-06
VECTORVISION SPINE
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HAW
2006-04-28
NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002
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HAW
2006-04-10
TOTAL KNEE SURGETICS NAVIGATION SYSTEM
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HAW
2006-04-10
SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM
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HAW
2006-03-23
IPLAN FLOW
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HAW
2006-03-21
BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS
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HAW
2006-03-20
VECTORVISION HIP
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HAW
2006-03-02
IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
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HAW
2006-02-13
CI KNEE, CI MI TKR
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HAW
2006-02-09
IPLAN
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HAW
2005-12-28
ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION
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HAW
2005-12-16
IGI-SYSTEM
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HAW
2005-11-23
GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955
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HAW
2005-11-18
VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS)
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HAW
2005-11-02
NAVIGATION SW HIP 3.1 ON CI
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HAW
2005-10-21
DEPUY CAS HIP INSTRUMENTATION
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HAW
2005-09-08
SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES
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HAW
2005-07-27
MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION
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HAW
2005-07-25
ELEKTA ESARTE FRAME SYSTEM
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HAW
2005-07-19
ACUMEN IMAGE GUIDED SURGICAL SYSTEM
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HAW
2005-06-08
STELTHSTATION WIRELESS SURGEON MOUSE
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HAW
2005-06-07
SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM
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HAW
2005-06-02
STEALTHSTATION SYSTEM UPDATE
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HAW
2005-06-01
MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01
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HAW
2005-05-24
NAVIPRO SHOULDER SOFTWARE MODULE
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HAW
2005-05-17
MODIFICATION TO: VOYAGER LINUX
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HAW
2005-05-17
IPLAN! DIGITAL TEMPLATING
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HAW
2005-04-27
AESCULAP ORTHOPILOT 2 THA V 2.0
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HAW
2005-04-21
NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000
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HAW
2005-04-21
STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-000
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HAW
2005-04-19
KOLIBRI SPINE
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HAW
2005-04-07
NBD HEAD SCREW
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HAW
2005-03-04
DEPUY CAS KNEE INSTRUMENTATION
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HAW
2005-02-10
VECTORVISION OSTEOTOMY
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HAW
2005-02-07
NAVIGUS NEXDRIVE, MODEL MI-3000
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HAW
2005-01-14
NAVITRACK SYSTEM - S&N IMAGE FREE KNEE
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HAW
2005-01-13
VECTORVISION ACL
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HAW
2005-01-05
MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE
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HAW
2004-12-09
PATHFINDER
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HAW
2004-10-22
IPLAN!
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HAW
2004-10-19
KOLIBRI IMAGE GUIDED SURGERY SYSTEM
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HAW
2004-10-06
VECTORVISION UNI-KNEE
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HAW
2004-10-04
NAVIGUS PASSIVE PROBE, MODEL NP-1000
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HAW
2004-09-22
IPLAN! FLOW
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HAW
2004-09-10
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
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