Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- OSFPatient Specific Manual Orthopedic Stereotaxic System2Product Code
- OJPOrthopedic Computer Controlled Surgical System2Product Code
- OLOOrthopedic Stereotaxic Instrument2Product Code
- K252962DYNAMIS™ Navigation System2Cleared 510(K)
- K253661TMINI Miniature Robotic System2Cleared 510(K)
- K252950Paradigm System2Cleared 510(K)
- K252841REAL INTELLIGENCE™ CORI™ XT (CORI XT)2Cleared 510(K)
- K251943Spineology Navigation Instruments2Cleared 510(K)
- K251314Rosa® Knee System2Cleared 510(K)
- K250599ExcelsiusGPS™ Instruments2Cleared 510(K)
- K252088Firebird SI Navigation System2Cleared 510(K)
- K252742Navigated Instruments2Cleared 510(K)
- K250520OsteoCentric Navigated Instruments System2Cleared 510(K)
- K251282StealthStation S8 Spine Software2Cleared 510(K)
- K252544TMINI Miniature Robotic System2Cleared 510(K)
- K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer2Cleared 510(K)
- K251780iGPS Navigation Instruments2Cleared 510(K)
- K252562Spine & Trauma Navigation Instruments2Cleared 510(K)
- K251316Mazor X System / Mazor X Stealth Edition2Cleared 510(K)
- K250167Evolution Spine Navigation Instruments2Cleared 510(K)
- K251060CORUS™ Navigation System-GX2Cleared 510(K)
- K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)2Cleared 510(K)
- K250877TMINI Miniature Robotic System2Cleared 510(K)
- K242933SPINEART Navigation Instrument System2Cleared 510(K)
- K242464Stealth™ Spine Clamps; ModuLeX™ Shank Mounts2Cleared 510(K)
- K250879Paradigm System2Cleared 510(K)
- K251315Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II2Cleared 510(K)
- K250086OTS Hip2Cleared 510(K)
- K243419Altus Spine Navigation System2Cleared 510(K)
- K250608Mako Total Knee Application (3.0); Hybrid Tip Pointer2Cleared 510(K)
- K243326Dynamis Robotic Surgical System2Cleared 510(K)
- K242806Medyssey Navigation System2Cleared 510(K)
- K243514Salvo® Robotic Navigation Instruments2Cleared 510(K)
- K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments2Cleared 510(K)
- K250182Innovasis Navigation Instruments2Cleared 510(K)
- K243958Consolidated Operating Room Equipment (CORE) 2 Console2Cleared 510(K)
- K242121mBôs (Monogram mBôs TKA System)2Cleared 510(K)
- K242914Op.n(TM) Navigation2Cleared 510(K)
- K242890SPINEART Navigation Instrument System2Cleared 510(K)
- K243751Mako Total Hip Application 5.02Cleared 510(K)
- K243258Paradigm System2Cleared 510(K)
- K243387GYDER® Hip System2Cleared 510(K)
- K243814NuVasive Pulse System2Cleared 510(K)
- K243481TMINI Miniature Robotic System2Cleared 510(K)
- K243671ExcelsiusGPS® Instruments2Cleared 510(K)
- K243560Remex Spine Surgery Navigation Instrument2Cleared 510(K)
- K243073AnyPlus Navigated Instruments System2Cleared 510(K)
- K243285TMINI Miniature Robotic System2Cleared 510(K)
- K242373Mako Shoulder Application (1.0)2Cleared 510(K)
- K242864ROSA® Knee System2Cleared 510(K)
- K240160EGPS Navigated Instruments2Cleared 510(K)
- K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays2Cleared 510(K)
- K241517Q Guidance System; Mako Spine System;2Cleared 510(K)
- K242264TMINI Miniature Robotic System2Cleared 510(K)
- K242009360CAS Knee2Cleared 510(K)
- K241644SPINEART Navigation Instrument System2Cleared 510(K)
- K233706Bendini Cloud Application2Cleared 510(K)
- K233725Spine Navigation System2Cleared 510(K)
- K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories2Cleared 510(K)
- K241130“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)2Cleared 510(K)
- K241031TMINI Miniature Robotic System (TMINI 1.1)2Cleared 510(K)
- K241625Anatase Navi Disposable Instrument2Cleared 510(K)
- K233256Robotic Integration Instruments2Cleared 510(K)
- K233255CROSSNAV Navigation Enabled Instruments2Cleared 510(K)
- K241082INNOVERSE Navigation Instruments2Cleared 510(K)
- K240721ExcelsiusFlex™2Cleared 510(K)
- K233228Spine Navigation and Robotic-Assistance Device2Cleared 510(K)
- K233254TELIGEN System Navigation Ready Instruments2Cleared 510(K)
- K241011Mako Total Knee Application2Cleared 510(K)
- K240951Invictus Robotic Navigation Instruments2Cleared 510(K)
- K240662Spine 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 Handpiece2Cleared 510(K)
- K240211VELYS Robotic-Assisted Solution2Cleared 510(K)
- K240701Drill Guide; Drill Bit; Spine & Trauma Navigation2Cleared 510(K)
- K240625CORUS Navigation Access System2Cleared 510(K)
- K233513Remex Spine Surgery Navigation System II2Cleared 510(K)
- K240568DuraPro™ Oscillating System2Cleared 510(K)
- K240062ARVIS® Shoulder2Cleared 510(K)
- K233172NextAR™ Spine Platform2Cleared 510(K)
- K240647Virage® Navigation System2Cleared 510(K)
- K233595Genesys Spine Sacroiliac Joint Fusion System with Navigation2Cleared 510(K)
- K234047Automatic Registration2Cleared 510(K)
- K240139Real Intelligence™ CORI™2Cleared 510(K)
- K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System2Cleared 510(K)
- K232140OTS Hip2Cleared 510(K)
- K233899Knee+2Cleared 510(K)
- K230195Neo ADVISE software2Cleared 510(K)
- K232800Navigation Tracking Instruments2Cleared 510(K)
- K233199ROSA® Shoulder System2Cleared 510(K)
- K233638VERZA™ High Speed Drills2Cleared 510(K)
- K233299ExactechGPS® System2Cleared 510(K)
- K233227VELYS™ Robotic-Assisted Solution2Cleared 510(K)
- K232572Kalitec Navigated Instrument System2Cleared 510(K)
- K230700RIWOtrack Navigation System2Cleared 510(K)
- K233443Vital™ Navigation System2Cleared 510(K)
- K232533ROSA Partial Knee System2Cleared 510(K)
- K232521ExactechGPS® Total Ankle Application2Cleared 510(K)
- K232345ATEC Posterior Navigated Disc Prep Instruments2Cleared 510(K)
- K232176STELLAR Knee2Cleared 510(K)
- K232280NextAR™ TSA Platform2Cleared 510(K)
- K231494CoreLink Robotic Navigation Instruments2Cleared 510(K)
- K232802TMINI™ Miniature Robotic System2Cleared 510(K)
- K232044Invictus Robotic Navigation Instruments2Cleared 510(K)
- K231527TriALTIS Navigation Enabled Instruments2Cleared 510(K)
- K232413Fusion Robotic Navigation System2Cleared 510(K)
- K231284OnPoint Augmented Reality Spine System2Cleared 510(K)
- K231611HOLO Portal™ Surgical Guidance System2Cleared 510(K)
- K232116CoreLink Navigation Instruments2Cleared 510(K)
- K223553Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine2Cleared 510(K)
- K231963REAL INTELLIGENCE™ CORI™2Cleared 510(K)
- K231886SURGIVISIO Device2Cleared 510(K)
- K231172ApolloKnee2Cleared 510(K)
- K223769NextAR™ Spine Platform2Cleared 510(K)
- K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System2Cleared 510(K)
- K230716Robotic Graft Delivery Instruments2Cleared 510(K)
- K230087“POINT” Kinguide Agile Hybrid Navigation System2Cleared 510(K)
- K223808Zavation Navigation Instrument System2Cleared 510(K)
- K230876RI.KNEE Adjustable Tibia Cut Guide2Cleared 510(K)
- K230861VADER® Pedicle System Navigated Instruments2Cleared 510(K)
- K230369EUROPA™ Navigated Instruments2Cleared 510(K)
- K223558CUVIS-spine2Cleared 510(K)
- K230567OptiVu™ ROSA® MxR2Cleared 510(K)
- K231184CD Horizon™ Spinal System2Cleared 510(K)
- K231229S-COMP Reform® POCT Navigation Instruments2Cleared 510(K)
- K230989Rod Registration Frame2Cleared 510(K)
- K230880CoreLink Navigation Instruments2Cleared 510(K)
- K223511Excella Navigation Instruments2Cleared 510(K)
- K230202TMINI™ Miniature Robotic System2Cleared 510(K)
- K230783Anatase Spine Surgery Navigation System2Cleared 510(K)
- K230789Knee+2Cleared 510(K)
- K222291Paradigm System2Cleared 510(K)
- K230064Mazor X System (Mazor X Stealth Edition)2Cleared 510(K)
- K230243ROSA® Knee System2Cleared 510(K)
- K223765ATEC Lateral Navigation Instruments2Cleared 510(K)
- K223350Remi Robotic Navigation System2Cleared 510(K)
- K222355PathKeeper System2Cleared 510(K)
- K230180Rosa Knee System2Cleared 510(K)
- K223767Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System2Cleared 510(K)
- K223351Naviswiss Knee2Cleared 510(K)
- K223927360CAS2Cleared 510(K)
- K222510Blueprint Mixed Reality system2Cleared 510(K)
- K223108TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)2Cleared 510(K)
- K223200Curiteva Navigation System2Cleared 510(K)
- K223649VERTICALE® Navigation Instruments2Cleared 510(K)
- K220554Caduceus S2Cleared 510(K)
- K222753SeaSpine 7D Navigation Instruments2Cleared 510(K)
- K220774RobPath® Total Hip Application2Cleared 510(K)
- K220905xvision Spine System2Cleared 510(K)
- K223070Remi Robotic Navigation System2Cleared 510(K)
- K222966Cirq Arm System (2.0);Alignment System Spine2Cleared 510(K)
- K222698CUVIS-spine2Cleared 510(K)
- K221928ROSA® Knee System2Cleared 510(K)
- K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) Edition2Cleared 510(K)
- K213034SpineAR SNAP2Cleared 510(K)
- K220104Knee+2Cleared 510(K)
- K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System2Cleared 510(K)
- K221224REAL INTELLIGENCE CORI2Cleared 510(K)
- K220241“POINT” Kinguide Robotic-Assisted Surgical System2Cleared 510(K)
- K213876Spineology Navigation Instruments2Cleared 510(K)
- K220958Real Intelligence Cori2Cleared 510(K)
- K220862E-GPS Navigated Instruments2Cleared 510(K)
- K220348Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V2Cleared 510(K)
- K213873SkyWalker Total Knee System2Cleared 510(K)
- K221028SURGIVISIO Device2Cleared 510(K)
- K220024ChoiceSpine Navigation System2Cleared 510(K)
- K220652Knee 32Cleared 510(K)
- K220973CoreLink Navigation Instruments2Cleared 510(K)
- K220593Spine Guidance Software, Stryker Q Guidance System2Cleared 510(K)
- K220146VisAR2Cleared 510(K)
- K221180Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments2Cleared 510(K)
- K2205227D Surgical System - Percutaneous Application (7D Flash Frame)2Cleared 510(K)
- K213491Universal Pilot Guidance Instrument System2Cleared 510(K)
- K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set2Cleared 510(K)
- K213877ExactechGPS® System2Cleared 510(K)
- K220038Camber Spine Navigation System2Cleared 510(K)
- K213708ROSA® Knee System2Cleared 510(K)
- K220459Mako Total Knee Application2Cleared 510(K)
- K212245Spine 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 Planning2Cleared 510(K)
- K220291NEXXT SPINE NAVIGATION System2Cleared 510(K)
- K220255REAL INTELLIGENCE CORI2Cleared 510(K)
- K213751NextAR™ TKA Platform My Knee PPS2Cleared 510(K)
- K214011Catalyft™ 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 Drivers2Cleared 510(K)
- K213918DeGen Navigated Instrumentation2Cleared 510(K)
- K214059CoreLink Navigation Instruments2Cleared 510(K)
- K213033iASSIST Knee System2Cleared 510(K)
- K211254ARAI Surgical Navigation System2Cleared 510(K)
- K213380360CAS2Cleared 510(K)
- K213720Vital Navigation System2Cleared 510(K)
- K213546ExactechGPS Total Shoulder Application, Equinoxe Planning Software2Cleared 510(K)
- K212088Integrity Implants Navigated Instruments2Cleared 510(K)
- K210859NextAR™ Spine Platform2Cleared 510(K)
- K212537REAL INTELLIGENCE CORI (CORI)2Cleared 510(K)
- K212825CoreLink Navigation Instruments2Cleared 510(K)
- K212028Dark Star Navigation Instrument System2Cleared 510(K)
- K212023Virage Navigation System2Cleared 510(K)
- K211616ExcelsiusHub2Cleared 510(K)
- K202836GX Navigation Instrument System2Cleared 510(K)
- K212007VERTICALE Navigation Instruments2Cleared 510(K)
- K210574NuVasive Pulse System2Cleared 510(K)
- K211188xvision Spine system (XVS)2Cleared 510(K)
- K203115ARVIS Surgical Navigation System2Cleared 510(K)
- K211442StealthStation Spinous Process Clamps2Cleared 510(K)
- K211596CD Horizon Spinal System2Cleared 510(K)
- K2104577D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key2Cleared 510(K)
- K211441Navigated Anterolateral Disc Prep Instruments2Cleared 510(K)
- K201569CUVIS-spine2Cleared 510(K)
- K210153NextAR RSA Platform2Cleared 510(K)
- K202750Knee+2Cleared 510(K)
- K210121ROSA Partial Knee System2Cleared 510(K)
- K203751OMNIVision system2Cleared 510(K)
- K203816DeGen Navigated Instrumentation2Cleared 510(K)
- K210668TSolution One Total Knee Application2Cleared 510(K)
- K2105557D Surgical System - Drill Guide2Cleared 510(K)
- K203205Navigated Spine Instruments2Cleared 510(K)
- K210472SPINEART Navigation Instrument System2Cleared 510(K)
- K203679Automatic Registration2Cleared 510(K)
- K202956Erisma LP Navigated Instruments2Cleared 510(K)
- K202184Practical Navigation Surgical Guidance System (PNSGS)2Cleared 510(K)
- K203573RESPONSE Navigation Instruments2Cleared 510(K)
- K202769VELYS™ Robotic-Assisted Solution2Cleared 510(K)
- K203561ChoiceSpine Navigation System2Cleared 510(K)
- K202320CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System2Cleared 510(K)
- K202749ADAPT for Gamma32Cleared 510(K)
- K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration2Cleared 510(K)
- K203291CD Horizon Spinal System Instruments2Cleared 510(K)
- K200719NuVasive Navigation.S Instruments2Cleared 510(K)
- K203040TSolution One Total Knee Application2Cleared 510(K)
- K203110iFuse Implant System - iFuse Navigation2Cleared 510(K)
- K202552Midas Rex Attachments and Dissecting Tools2Cleared 510(K)
- K203005Mazor X2Cleared 510(K)
- K202152NextAR TKA Platform2Cleared 510(K)
- K201661Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set2Cleared 510(K)
- K200845Navigation Module of the Momentum System2Cleared 510(K)
- K192653Perseus2Cleared 510(K)
- K2019667D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array2Cleared 510(K)
- K193618ExactechGPS System2Cleared 510(K)
- K201006K2M Navigation Instruments2Cleared 510(K)
- K201251CarboClear Navigated Instruments2Cleared 510(K)
- K200791Navigation Enabled Intruments2Cleared 510(K)
- K192663Joimax Intracs System2Cleared 510(K)
- K193515Mako Total Knee Application2Cleared 510(K)
- K200047ExcelsiusGPS Cranial 1.0 Module2Cleared 510(K)
- K200888OMNIBotics Knee System2Cleared 510(K)
- K200095Streamline Navigated Instruments2Cleared 510(K)
- K201327NavLock Trackers2Cleared 510(K)
- K200892Harvey(R) Surgical Assistant2Cleared 510(K)
- K201022REAL INTELLIGENCE CORI (CORI)2Cleared 510(K)
- K201255TSolution® One Total Knee Application2Cleared 510(K)
- K193094Naviswiss Hip Navigation System2Cleared 510(K)
- K193307HIP72Cleared 510(K)
- K201189Stealthstation S8 Spine Software v1.3.02Cleared 510(K)
- K200935Mazor X2Cleared 510(K)
- K200642OrthAlign Plus System2Cleared 510(K)
- K193120Real Intelligence Cori2Cleared 510(K)
- K193128Mako Total Hip Application2Cleared 510(K)
- K192495Black Diamond Navigation Instruments2Cleared 510(K)
- K190929xvision Spine system (XVS)2Cleared 510(K)
- K190881Spinal Elements Navigated Instruments2Cleared 510(K)
- K182731Corelink Navigation Instruments2Cleared 510(K)
- K193135TSolution One Total Knee Application2Cleared 510(K)
- K191722Vital Navigation System2Cleared 510(K)
- K192336Navigated Anterolateral Disc Prep Instruments2Cleared 510(K)
- K192911Brainlab Compatible K2M Navigation Instruments2Cleared 510(K)
- K1921407D Surgical System2Cleared 510(K)
- K192080iASSIST Knee System2Cleared 510(K)
- K192173ROSA ONE Spine application2Cleared 510(K)
- K192133Zimmer Biomet Universal Navigation System2Cleared 510(K)
- K190556Zimmer Biomet Universal Navigation System2Cleared 510(K)
- K191943SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set2Cleared 510(K)
- K192526Spine Wave Navigated Instruments2Cleared 510(K)
- K191854Premia Spine XL Instruments2Cleared 510(K)
- K191369TSolution One Total Knee Application2Cleared 510(K)
- K191507Intellijoint® Navigation System2Cleared 510(K)
- K181606Precision Spine Navigation Instrumentation2Cleared 510(K)
- K191998Mako Total Hip Application, Mako Total Knee Application2Cleared 510(K)
- K180523INTAI Surgery Navigation System2Cleared 510(K)
- K183605Spine & Trauma Navigation2Cleared 510(K)
- K191039Navigated T2 STRATOSPHERE Inserters and Navigated Templates2Cleared 510(K)
- K191012Navigated Pedicle Access Kit2Cleared 510(K)
- K191100ExcelsiusGPS Spine 1.1 Interbody Module2Cleared 510(K)
- K191223NAVIO2Cleared 510(K)
- K182524GALILEO Spine Alignment Monitoring System2Cleared 510(K)
- K191285Spine & Trauma Navigation2Cleared 510(K)
- K183630SPINEART Navigation Instrument System2Cleared 510(K)
- K183644Stealth-Midas MR8 System2Cleared 510(K)
- K183381Navigation Enabled Instruments2Cleared 510(K)
- K190653ExcelsiusGPS2Cleared 510(K)
- K182848ROSA ONE Spine application2Cleared 510(K)
- K183196Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker2Cleared 510(K)
- K182964ROSA Knee System2Cleared 510(K)
- K182721Choice Spine Navigation System2Cleared 510(K)
- K182982BridalVeil Navigated Instruments2Cleared 510(K)
- K181890Brainlab Compatible K2M Navigation Instruments2Cleared 510(K)
- K182121CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition2Cleared 510(K)
- K182104NavLock Trackers, Robotic Reference Frame2Cleared 510(K)
- K182077Mazor X System (Mazor X Stealth Edition)2Cleared 510(K)
- K181596Spine Wave Navigated Instruments2Cleared 510(K)
- K181848ADAPT for Gamma3, Gamma32Cleared 510(K)
- K182345Spineology Navigation Instruments2Cleared 510(K)
- K181449Ortoma Treatment Solution - OTS2Cleared 510(K)
- K180816Ziehm RFD 3D Tracker2Cleared 510(K)
- K180038NuVasive Pulse System2Cleared 510(K)
- K180690Navigation Instruments2Cleared 510(K)
- K181111Navigated INFINITY Instruments2Cleared 510(K)
- K172517SeaSpine Navigation System2Cleared 510(K)
- K180796Spineology Navigation Instruments2Cleared 510(K)
- K1803527D Surgical System2Cleared 510(K)
- K173946ADAPT for Gamma32Cleared 510(K)
- K180307Mazor X2Cleared 510(K)
- K172166OLYMPIC Navigated Instruments2Cleared 510(K)
- K180277Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter2Cleared 510(K)
- K180271NAVIO™ Surgical System (NAVIO system)2Cleared 510(K)
- K172115Navigated Instrument System2Cleared 510(K)
- K173338Navigated INFINITY™ Instruments2Cleared 510(K)
- K171556K2M Navigation Instruments2Cleared 510(K)
- K172518Spineology Navigation Instruments2Cleared 510(K)
- K172623NuVasive Navigation Instruments2Cleared 510(K)
- K173372ExactechGPS Total Shoulder Application2Cleared 510(K)
- K172462OrthAlign Plus System2Cleared 510(K)
- K172849Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray2Cleared 510(K)
- K172301Mako Partial Knee Application2Cleared 510(K)
- K172268iFuse Implant System- iFuse Navigation2Cleared 510(K)
- K171525Intellijoint HIP Generation 2B System2Cleared 510(K)
- K172034Stryker 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 Tap2Cleared 510(K)
- K172219Mako Total Knee Application2Cleared 510(K)
- K172522Mazor X2Cleared 510(K)
- K170937VIPER PRIME navigated inserter2Cleared 510(K)
- K163338OMNIBotics Knee System2Cleared 510(K)
- K171321K2M Navigation Instruments2Cleared 510(K)
- K171651EXCELSIUS GPS2Cleared 510(K)
- K171780OrthAlign Plus System2Cleared 510(K)
- K171267NavLock Trackers2Cleared 510(K)
- K170891Mako Partial Knee Application2Cleared 510(K)
- K170584Mako Partial Knee Application2Cleared 510(K)
- K170581Mako Total Knee Application2Cleared 510(K)
- K170977SURESHOT Distal Targeting System V4.0 Trauma Interface2Cleared 510(K)
- K170360NAVIO2Cleared 510(K)
- K170011StealthStation S8 Spine Software v1.0.02Cleared 510(K)
- K170280Smith & Nephew SURESHOT Distal Targeting System V4.02Cleared 510(K)
- K170593Mako Total Hip Application2Cleared 510(K)
- K163581Navigated ELEVATE Inserter, Navigated Disc Prep Instruments2Cleared 510(K)
- K162567ExactechGPS Total Shoulder Application, Equinoxe Planning Software2Cleared 510(K)
- K163221Mazor X2Cleared 510(K)
- K162921Navigated Instrument System2Cleared 510(K)
- K170430TSolution One Surgical System Model 2102Cleared 510(K)
- K163379KneeAlign 2 System2Cleared 510(K)
- K162364Intellijoint HIP Generation 2A System2Cleared 510(K)
- K162937Stryker OrthoMap Versatile Hip System2Cleared 510(K)
- K162962OrthAlign Plus System2Cleared 510(K)
- K162375Envision 3D: Image Guidance System2Cleared 510(K)
- K162341Stryker OrthoMap Precision Knee system2Cleared 510(K)
- K162195TSolution One Cup1 Surgical System2Cleared 510(K)
- K160385Precision Screw2Cleared 510(K)
- K153700Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments2Cleared 510(K)
- K153240Styrker OrthoMap Express Knee System2Cleared 510(K)
- K160713Stealth-Midas System2Cleared 510(K)
- K160537Navio2Cleared 510(K)
- K153396Aesculap OrthoPilot Next Generation2Cleared 510(K)
- K153603Alphatec Navigation Instruments2Cleared 510(K)
- K153237OrthAlign Plus System2Cleared 510(K)
- K153647TSolution One w/ACG+ Surgical System2Cleared 510(K)
- K153203Navigation Instruments2Cleared 510(K)
- K151511ROSA Spine2Cleared 510(K)
- K151364Intellijoint HIP(tm) System2Cleared 510(K)
- K152041Renaissance X System2Cleared 510(K)
- K152574Navio2Cleared 510(K)
- K142530Partial Knee Application (PKA)2Cleared 510(K)
- K143597Navigated XIA 4.5 Polyaxial Screwdriver2Cleared 510(K)
- K143752Total Knee Application (TKA)2Cleared 510(K)
- K150231Navigated Disc Prep Instruments and CAPSTONE Trials2Cleared 510(K)
- K143668Navio2Cleared 510(K)
- K141694AESCULAP ORTHOPILOT NEXT GENERATION2Cleared 510(K)
- K143628Navigated Vertex Select Instruments2Cleared 510(K)
- K141989MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM2Cleared 510(K)
- K141941SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES D2Cleared 510(K)
- K140927UNIVERSAL NAVIGATION INSTRUMENTS2Cleared 510(K)
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- K140167RENAISSANCE X SYSTEM2Cleared 510(K)
- K140689IKNEE DISTAL FEMORAL CUTTING GUIDE2Cleared 510(K)
- K133759INTELLIJOINT HIP2Cleared 510(K)
- K140596NAVIO2Cleared 510(K)
- K140331ORTHALIGN PLUS SYSTEM2Cleared 510(K)
- K140454NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS2Cleared 510(K)
- K130387ORTHOALIGN PLUS SYSTEM2Cleared 510(K)
- K131425NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER2Cleared 510(K)
- K130887S4C NAVIGATION INSTRUMENTS2Cleared 510(K)
- K130748SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.02Cleared 510(K)
- K131130NAVIGATION PIN2Cleared 510(K)
- K124004NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS2Cleared 510(K)
- K121765SCULPTOR ROBOTIC GUIDANCE ARM (RGA)2Cleared 510(K)
- K122742NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM2Cleared 510(K)
- K122326SMARTTOOLS KNEE SYSTEM2Cleared 510(K)
- K121936NAVIOPFS2Cleared 510(K)
- K122011NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP2Cleared 510(K)
- K120867VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS2Cleared 510(K)
- K121064MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM2Cleared 510(K)
- K112507RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM2Cleared 510(K)
- K111811BENDINI(TM) SPINAL ROD BENDING SYSTEM2Cleared 510(K)
- K111843ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM2Cleared 510(K)
- K110021DASH HIP2Cleared 510(K)
- K111443X12 STERILE REFLECTIVE MARKER SPHERE2Cleared 510(K)
- K110204BRAINLAB TRAUMA2Cleared 510(K)
- K102251DASH KNEE2Cleared 510(K)
- K110240SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.12Cleared 510(K)
- K103829KNEEALIGN SYSTEM2Cleared 510(K)
- K102990BRAINLAB KNEE2Cleared 510(K)
- K110054NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE2Cleared 510(K)
- K103400FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP2Cleared 510(K)
- K102967SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.22Cleared 510(K)
- K100742EXACTECH GPS2Cleared 510(K)
- K093206ORTHOMAP 3D 1.1 MODULE2Cleared 510(K)
- K093118BRAINLAB KNEE ARTHROSCOPY2Cleared 510(K)
- K100599CAS 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 MM2Cleared 510(K)
- K093998KNEEALIGN SYSTEM WITH REFERENCE SENSOR2Cleared 510(K)
- K093425MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA2Cleared 510(K)
- K100107SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.02Cleared 510(K)
- K090953TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK2Cleared 510(K)
- K091998ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP2Cleared 510(K)
- K091411KNEEALIGN SYSTEM2Cleared 510(K)
- K092497SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.12Cleared 510(K)
- K090375ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS2102Cleared 510(K)
- K083644MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP2Cleared 510(K)
- K090420SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.02Cleared 510(K)
- K083483BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED2Cleared 510(K)
- K083310SPINE & TRAUMA ICT2Cleared 510(K)
- K090313PIGALILEO TKR BASE V2.3 AND CAS V4.12Cleared 510(K)
- K083009ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-0002Cleared 510(K)
- K083872IMNS MEDACTA NAVIGATION SYSTEM2Cleared 510(K)
- ONNIntraoperative Orthopedic Joint Assessment Aid2Product Code
- OSEPatient Specific Manual Navigation System2Product Code
- SBFOrthopedic Augmented Reality2Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Harvey(R) Surgical Assistant
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K200892
- 510(k) Type
- Special
- Applicant
- Orthalign, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/18/2020
- Days to Decision
- 76 days
- Submission Type
- Summary