BEUDAMED
    Product Code: OLO FDA class 2 21 CFR 882.4560

    Orthopedic Stereotaxic Instrument

    Neurology

    The Orthopedic Stereotaxic Instrument (product code OLO) is a Class 2 device regulated under 21 CFR 882.4560 in the Neurology specialty (NE), cleared through the 510(k) pathway and reviewed by the Orthopedic panel. It provides stereotaxic guidance during orthopedic surgical procedures including joint or spine surgery, and is distinct from neurological stereotaxic instruments classified under product code HAW. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    431
    FEI Numbers
    381
    Registration Numbers
    381
    Unique Applicants
    144
    Years Active
    17

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    Basic Information

    Product Code
    OLO
    Device Class
    FDA class 2
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 431 510(k) clearances via K numbers.

    K Number Device Name
    K260369 Dynamis Robotic Surgical System
    K261665 CORUS™ Navigation System-GN
    K260571 SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
    K261060 Navigated LLIF Impactable Tracker
    K254157 CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody
    K260329 Ion-C Navigation Instruments
    K260582 ROSA® Shoulder System
    K252880 Pytheas Your Guided Trajectory
    K260011 Foundation Surgical Navigated Lateral Disc Prep Instruments
    K254158 SPINEART Navigation Instrument System
    K260240 SYMPHONY Navigation Ready Instruments
    K260601 REAL INTELLIGENCE™ CORI™
    K252037 CUVIS-joint (CJ150)
    K253604 TiLink-L Navigation Instruments
    K253444 EUROPA™ Posterior Cervical Fusion Navigated Instruments
    K260546 Q Pedicle Instruments
    K260010 TMINI® Miniature Robotic System
    K260222 Mako Total Knee Application
    K252989 “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set
    K254148 VERTICALE GPS Instruments
    K253623 Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor
    K252597 Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)
    K253381 Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application
    K252873 Q Interbody Instruments
    K252871 Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories
    K252058 ROSA Knee System with UltraSound Imaging Platform (USIP)
    K252087 Navigation Module of the Cortium® System
    K252755 POINT Kinguide Agile Robotic Arm Surgical Stereotactic System
    K252962 DYNAMIS™ Navigation System
    K253661 TMINI Miniature Robotic System
    K252950 Paradigm System
    K252841 REAL INTELLIGENCE™ CORI™ XT (CORI XT)
    K251943 Spineology Navigation Instruments
    K251314 Rosa® Knee System
    K250599 ExcelsiusGPS™ Instruments
    K252088 Firebird SI Navigation System
    K252742 Navigated Instruments
    K250520 OsteoCentric Navigated Instruments System
    K251282 StealthStation S8 Spine Software
    K252544 TMINI Miniature Robotic System
    K251971 RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer
    K251780 iGPS Navigation Instruments
    K252562 Spine & Trauma Navigation Instruments
    K251316 Mazor X System / Mazor X Stealth Edition
    K250167 Evolution Spine Navigation Instruments
    K251060 CORUS™ Navigation System-GX
    K251073 Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)
    K250877 TMINI Miniature Robotic System
    K242933 SPINEART Navigation Instrument System
    K242464 Stealth™ Spine Clamps; ModuLeX™ Shank Mounts
    K250879 Paradigm System
    K251315 Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II
    K250086 OTS Hip
    K243419 Altus Spine Navigation System
    K250608 Mako Total Knee Application (3.0); Hybrid Tip Pointer
    K243326 Dynamis Robotic Surgical System
    K242806 Medyssey Navigation System
    K243514 Salvo® Robotic Navigation Instruments
    K243659 FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments
    K250182 Innovasis Navigation Instruments
    K243958 Consolidated Operating Room Equipment (CORE) 2 Console
    K242121 mBôs (Monogram mBôs TKA System)
    K242914 Op.n(TM) Navigation
    K242890 SPINEART Navigation Instrument System
    K243751 Mako Total Hip Application 5.0
    K243258 Paradigm System
    K243387 GYDER® Hip System
    K243814 NuVasive Pulse System
    K243481 TMINI Miniature Robotic System
    K243671 ExcelsiusGPS® Instruments
    K243560 Remex Spine Surgery Navigation Instrument
    K243073 AnyPlus Navigated Instruments System
    K243285 TMINI Miniature Robotic System
    K242373 Mako Shoulder Application (1.0)
    K242864 ROSA® Knee System
    K240160 EGPS Navigated Instruments
    K241893 CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays
    K241517 Q Guidance System; Mako Spine System;
    K242264 TMINI Miniature Robotic System
    K242009 360CAS Knee
    K241644 SPINEART Navigation Instrument System
    K233706 Bendini Cloud Application
    K233725 Spine Navigation System
    K241171 Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories
    K241130 “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)
    K241031 TMINI Miniature Robotic System (TMINI 1.1)
    K241625 Anatase Navi Disposable Instrument
    K233256 Robotic Integration Instruments
    K233255 CROSSNAV Navigation Enabled Instruments
    K241082 INNOVERSE Navigation Instruments
    K240721 ExcelsiusFlex™
    K233254 TELIGEN System Navigation Ready Instruments
    K233228 Spine Navigation and Robotic-Assistance Device
    K241011 Mako Total Knee Application
    K240951 Invictus Robotic Navigation Instruments
    K240662 Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece
    K240211 VELYS Robotic-Assisted Solution
    K240701 Drill Guide; Drill Bit; Spine & Trauma Navigation
    K240625 CORUS Navigation Access System
    K233513 Remex Spine Surgery Navigation System II
    K240568 DuraPro™ Oscillating System
    K240062 ARVIS® Shoulder
    K240647 Virage® Navigation System
    K233595 Genesys Spine Sacroiliac Joint Fusion System with Navigation
    K234047 Automatic Registration
    K240139 Real Intelligence™ CORI™
    K233542 Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System
    K232140 OTS Hip
    K230195 Neo ADVISE software
    K232800 Navigation Tracking Instruments
    K233199 ROSA® Shoulder System
    K233638 VERZA™ High Speed Drills
    K233299 ExactechGPS® System
    K233227 VELYS™ Robotic-Assisted Solution
    K232572 Kalitec Navigated Instrument System
    K230700 RIWOtrack Navigation System
    K233443 Vital™ Navigation System
    K232533 ROSA Partial Knee System
    K232521 ExactechGPS® Total Ankle Application
    K232345 ATEC Posterior Navigated Disc Prep Instruments
    K231494 CoreLink Robotic Navigation Instruments
    K232802 TMINI™ Miniature Robotic System
    K232044 Invictus Robotic Navigation Instruments
    K231527 TriALTIS Navigation Enabled Instruments
    K232413 Fusion Robotic Navigation System
    K232116 CoreLink Navigation Instruments
    K223553 Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine
    K231963 REAL INTELLIGENCE™ CORI™
    K231886 SURGIVISIO Device
    K231172 ApolloKnee
    K223301 ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System
    K230716 Robotic Graft Delivery Instruments
    K230087 “POINT” Kinguide Agile Hybrid Navigation System
    K223808 Zavation Navigation Instrument System
    K230876 RI.KNEE Adjustable Tibia Cut Guide
    K230861 VADER® Pedicle System Navigated Instruments
    K230369 EUROPA™ Navigated Instruments
    K223558 CUVIS-spine
    K231184 CD Horizon™ Spinal System
    K231229 S-COMP Reform® POCT Navigation Instruments
    K230989 Rod Registration Frame
    K230880 CoreLink Navigation Instruments
    K223511 Excella Navigation Instruments
    K230202 TMINI™ Miniature Robotic System
    K230783 Anatase Spine Surgery Navigation System
    K222291 Paradigm System
    K230064 Mazor X System (Mazor X Stealth Edition)
    K230243 ROSA® Knee System
    K223765 ATEC Lateral Navigation Instruments
    K223350 Remi Robotic Navigation System
    K222355 PathKeeper System
    K230180 Rosa Knee System
    K223767 Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System
    K223351 Naviswiss Knee
    K223927 360CAS
    K222510 Blueprint Mixed Reality system
    K223108 TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)
    K223200 Curiteva Navigation System
    K223649 VERTICALE® Navigation Instruments
    K222753 SeaSpine 7D Navigation Instruments
    K220774 RobPath® Total Hip Application
    K223070 Remi Robotic Navigation System
    K222966 Cirq Arm System (2.0);Alignment System Spine
    K222698 CUVIS-spine
    K221928 ROSA® Knee System
    K222383 Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) Edition
    K221618 Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System
    K221224 REAL INTELLIGENCE CORI
    K220241 “POINT” Kinguide Robotic-Assisted Surgical System
    K213876 Spineology Navigation Instruments
    K220958 Real Intelligence Cori
    K220862 E-GPS Navigated Instruments
    K220348 Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V
    K213873 SkyWalker Total Knee System
    K221028 SURGIVISIO Device
    K220024 ChoiceSpine Navigation System
    K220652 Knee 3
    K220973 CoreLink Navigation Instruments
    K220593 Spine Guidance Software, Stryker Q Guidance System
    K220146 VisAR
    K221180 Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments
    K220522 7D Surgical System - Percutaneous Application (7D Flash Frame)
    K213491 Universal Pilot Guidance Instrument System
    K212756 Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set
    K213877 ExactechGPS® System
    K220038 Camber Spine Navigation System
    K213708 ROSA® Knee System
    K220459 Mako Total Knee Application
    K212245 Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning
    K220291 NEXXT SPINE NAVIGATION System
    K220255 REAL INTELLIGENCE CORI
    K214011 Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments, and CD Horizon™ Solera™ Voyager™ Spinal System Navigated, Guided, and Powered Drivers
    K213918 DeGen Navigated Instrumentation
    K214059 CoreLink Navigation Instruments
    K213033 iASSIST Knee System
    K213380 360CAS
    K213720 Vital Navigation System
    K213546 ExactechGPS Total Shoulder Application, Equinoxe Planning Software
    K212088 Integrity Implants Navigated Instruments
    K212537 REAL INTELLIGENCE CORI (CORI)
    K212825 CoreLink Navigation Instruments
    K212028 Dark Star Navigation Instrument System
    K212023 Virage Navigation System
    K211616 ExcelsiusHub
    K202836 GX Navigation Instrument System
    K212007 VERTICALE Navigation Instruments
    K210574 NuVasive Pulse System
    K203115 ARVIS Surgical Navigation System
    K211442 StealthStation Spinous Process Clamps
    K211596 CD Horizon Spinal System
    K210457 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key
    K211441 Navigated Anterolateral Disc Prep Instruments
    K201569 CUVIS-spine
    K210121 ROSA Partial Knee System
    K203751 OMNIVision system
    K203816 DeGen Navigated Instrumentation
    K210668 TSolution One Total Knee Application
    K210555 7D Surgical System - Drill Guide
    K203205 Navigated Spine Instruments
    K210472 SPINEART Navigation Instrument System
    K203679 Automatic Registration
    K202956 Erisma LP Navigated Instruments
    K202184 Practical Navigation Surgical Guidance System (PNSGS)
    K203573 RESPONSE Navigation Instruments
    K202769 VELYS™ Robotic-Assisted Solution
    K203561 ChoiceSpine Navigation System
    K202320 CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System
    K202749 ADAPT for Gamma3
    K200376 Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration
    K203291 CD Horizon Spinal System Instruments
    K200719 NuVasive Navigation.S Instruments
    K203040 TSolution One Total Knee Application
    K203110 iFuse Implant System - iFuse Navigation
    K202552 Midas Rex Attachments and Dissecting Tools
    K203005 Mazor X
    K201661 Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set
    K200845 Navigation Module of the Momentum System
    K192653 Perseus
    K201966 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array
    K193618 ExactechGPS System
    K201006 K2M Navigation Instruments
    K201251 CarboClear Navigated Instruments
    K200791 Navigation Enabled Intruments
    K192663 Joimax Intracs System
    K193515 Mako Total Knee Application
    K200047 ExcelsiusGPS Cranial 1.0 Module
    K200888 OMNIBotics Knee System
    K200095 Streamline Navigated Instruments
    K201327 NavLock Trackers
    K200892 Harvey(R) Surgical Assistant
    K201022 REAL INTELLIGENCE CORI (CORI)
    K201255 TSolution® One Total Knee Application
    K193094 Naviswiss Hip Navigation System
    K193307 HIP7
    K201189 Stealthstation S8 Spine Software v1.3.0
    K200935 Mazor X
    K200642 OrthAlign Plus System
    K193120 Real Intelligence Cori
    K193128 Mako Total Hip Application
    K192495 Black Diamond Navigation Instruments
    K190881 Spinal Elements Navigated Instruments
    K182731 Corelink Navigation Instruments
    K193135 TSolution One Total Knee Application
    K191722 Vital Navigation System
    K192336 Navigated Anterolateral Disc Prep Instruments
    K192911 Brainlab Compatible K2M Navigation Instruments
    K192140 7D Surgical System
    K192080 iASSIST Knee System
    K192173 ROSA ONE Spine application
    K192133 Zimmer Biomet Universal Navigation System
    K190556 Zimmer Biomet Universal Navigation System
    K191943 SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set
    K192526 Spine Wave Navigated Instruments
    K191854 Premia Spine XL Instruments
    K191369 TSolution One Total Knee Application
    K191507 Intellijoint® Navigation System
    K181606 Precision Spine Navigation Instrumentation
    K191998 Mako Total Hip Application, Mako Total Knee Application
    K180523 INTAI Surgery Navigation System
    K183605 Spine & Trauma Navigation
    K191039 Navigated T2 STRATOSPHERE Inserters and Navigated Templates
    K191012 Navigated Pedicle Access Kit
    K191100 ExcelsiusGPS Spine 1.1 Interbody Module
    K191223 NAVIO
    K182524 GALILEO Spine Alignment Monitoring System
    K191285 Spine & Trauma Navigation
    K183630 SPINEART Navigation Instrument System
    K183644 Stealth-Midas MR8 System
    K183381 Navigation Enabled Instruments
    K190653 ExcelsiusGPS
    K182848 ROSA ONE Spine application
    K183196 Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker
    K182964 ROSA Knee System
    K182721 Choice Spine Navigation System
    K182982 BridalVeil Navigated Instruments
    K181890 Brainlab Compatible K2M Navigation Instruments
    K182121 CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition
    K182104 NavLock Trackers, Robotic Reference Frame
    K182077 Mazor X System (Mazor X Stealth Edition)
    K181596 Spine Wave Navigated Instruments
    K181848 ADAPT for Gamma3, Gamma3
    K182345 Spineology Navigation Instruments
    K181449 Ortoma Treatment Solution - OTS
    K180816 Ziehm RFD 3D Tracker
    K180038 NuVasive Pulse System
    K180690 Navigation Instruments
    K181111 Navigated INFINITY Instruments
    K172517 SeaSpine Navigation System
    K180796 Spineology Navigation Instruments
    K180352 7D Surgical System
    K173946 ADAPT for Gamma3
    K180307 Mazor X
    K172166 OLYMPIC Navigated Instruments
    K180277 Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter
    K180271 NAVIO™ Surgical System (NAVIO system)
    K172115 Navigated Instrument System
    K173338 Navigated INFINITY™ Instruments
    K171556 K2M Navigation Instruments
    K172518 Spineology Navigation Instruments
    K172623 NuVasive Navigation Instruments
    K173372 ExactechGPS Total Shoulder Application
    K172462 OrthAlign Plus System
    K172849 Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray
    K172301 Mako Partial Knee Application
    K172268 iFuse Implant System- iFuse Navigation
    K171525 Intellijoint HIP Generation 2B System
    K172034 Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap
    K172219 Mako Total Knee Application
    K172522 Mazor X
    K170937 VIPER PRIME navigated inserter
    K163338 OMNIBotics Knee System
    K171321 K2M Navigation Instruments
    K171651 EXCELSIUS GPS
    K171780 OrthAlign Plus System
    K171267 NavLock Trackers
    K170891 Mako Partial Knee Application
    K170584 Mako Partial Knee Application
    K170581 Mako Total Knee Application
    K170977 SURESHOT Distal Targeting System V4.0 Trauma Interface
    K170360 NAVIO
    K170011 StealthStation S8 Spine Software v1.0.0
    K170280 Smith & Nephew SURESHOT Distal Targeting System V4.0
    K170593 Mako Total Hip Application
    K163581 Navigated ELEVATE Inserter, Navigated Disc Prep Instruments
    K162567 ExactechGPS Total Shoulder Application, Equinoxe Planning Software
    K163221 Mazor X
    K162921 Navigated Instrument System
    K170430 TSolution One Surgical System Model 210
    K163379 KneeAlign 2 System
    K162364 Intellijoint HIP Generation 2A System
    K162937 Stryker OrthoMap Versatile Hip System
    K162962 OrthAlign Plus System
    K162375 Envision 3D: Image Guidance System
    K162341 Stryker OrthoMap Precision Knee system
    K162195 TSolution One Cup1 Surgical System
    K160385 Precision Screw
    K153700 Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments
    K153240 Styrker OrthoMap Express Knee System
    K160713 Stealth-Midas System
    K160537 Navio
    K153396 Aesculap OrthoPilot Next Generation
    K153603 Alphatec Navigation Instruments
    K153237 OrthAlign Plus System
    K153647 TSolution One w/ACG+ Surgical System
    K153203 Navigation Instruments
    K151511 ROSA Spine
    K151364 Intellijoint HIP(tm) System
    K152041 Renaissance X System
    K152574 Navio
    K142530 Partial Knee Application (PKA)
    K143597 Navigated XIA 4.5 Polyaxial Screwdriver
    K143752 Total Knee Application (TKA)
    K150231 Navigated Disc Prep Instruments and CAPSTONE Trials
    K143668 Navio
    K141694 AESCULAP ORTHOPILOT NEXT GENERATION
    K143628 Navigated Vertex Select Instruments
    K141989 MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM
    K141941 SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES D
    K140927 UNIVERSAL NAVIGATION INSTRUMENTS
    K141601 IASSIST KNEE SYSTEM
    K140167 RENAISSANCE X SYSTEM
    K140689 IKNEE DISTAL FEMORAL CUTTING GUIDE
    K133759 INTELLIJOINT HIP
    K140596 NAVIO
    K140331 ORTHALIGN PLUS SYSTEM
    K140454 NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS
    K130387 ORTHOALIGN PLUS SYSTEM
    K131425 NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER
    K130887 S4C NAVIGATION INSTRUMENTS
    K130748 SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0
    K131130 NAVIGATION PIN
    K124004 NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS
    K121765 SCULPTOR ROBOTIC GUIDANCE ARM (RGA)
    K122742 NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM
    K122326 SMARTTOOLS KNEE SYSTEM
    K121936 NAVIOPFS
    K122011 NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP
    K120867 VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS
    K121064 MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM
    K112507 RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM
    K111811 BENDINI(TM) SPINAL ROD BENDING SYSTEM
    K111843 ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM
    K110021 DASH HIP
    K111443 X12 STERILE REFLECTIVE MARKER SPHERE
    K110204 BRAINLAB TRAUMA
    K102251 DASH KNEE
    K110240 SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1
    K103829 KNEEALIGN SYSTEM
    K102990 BRAINLAB KNEE
    K110054 NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE
    K103400 FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP
    K102967 SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2
    K100742 EXACTECH GPS
    K093206 ORTHOMAP 3D 1.1 MODULE
    K093118 BRAINLAB KNEE ARTHROSCOPY
    K100599 CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM
    K093998 KNEEALIGN SYSTEM WITH REFERENCE SENSOR
    K093425 MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA
    K100107 SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0
    K090953 TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK
    K091998 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP
    K091411 KNEEALIGN SYSTEM
    K092497 SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1
    K090375 ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210
    K083644 MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP
    K090420 SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0
    K083483 BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED
    K083310 SPINE & TRAUMA ICT
    K090313 PIGALILEO TKR BASE V2.3 AND CAS V4.1
    K083009 ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000
    K083872 IMNS MEDACTA NAVIGATION SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 381 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 381 registration numbers. Click on an entry to view related FDA registrations.