510(k) Report

Devices descending from K012380

273 later devices reach Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183196Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers…Stryker Corporation20190—
+1K172034Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock…Stryker Corporation201712—
+1K143597Navigated XIA 4.5 Polyaxial ScrewdriverStryker Corporate20150—
+1K141941Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap 3D…Stryker Corporate201422—
+1K140868Stryker Kwic NeedleOrthovita, Inc.20141—
+1K083009Ortho-Map-Oncology Navigation Software, Models 6005-650-000, 6005-651-000Stryker Leibinger GmbH & Co KG20091—
+1K040369Stryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments200478
+1K040300Stryker Consolidated Operating Room Equipment (Core)Stryker Instruments200478
+1K032303Stryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments20041465
+1K032117Stryker Total Performance (TPS) SystemStryker Instruments2003238—
+2K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+2K221028SURGIVISIO DeviceEcential Robotics20227—
+2K220593Spine Guidance Software, Stryker Q Guidance SystemStryker Leibinger GmbH & Co KG202210—
+2K203205Navigated Spine InstrumentsStryker Spine20218—
+2K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+2K132264PRIMADO2 Total Surgical SystemNakanishi, Inc.20136—
+2K092977Eberle Shaver System AccessoriesEfs Eberle Feinwerktechnische Systeme20101—
+2K093206Orthomap 3D 1.1 ModuleStryker Corp.20100—
+2K071859Stryker Crossfire SystemStryker Endoscopy200742
+2K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd.2004226—
+3K260546Q Pedicle InstrumentsK2m, Inc.20260—
+3K252873Q Interbody InstrumentsK2m, Inc.20260—
+3K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+3K252666Articulator Arthroscopic BurJoint Preservation Innovations, LLC20250—
+3K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K231886SURGIVISIO DeviceEcential Robotics20236—
+3K223767Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho…Stryker Leibinger GmbH & Co KG20231—
+3K213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH20221—
+3K202120P300 AttachmentNakanishi, Inc.20211—
+3K193608EBERLE Shaver System C3 and AccessoriesEberle GmbH & Co. KG20210—
+3K162770Relign SystemRelign Corporation20172—
+3K061966Litetouch Dental Laser SystemLight Instrument, Ltd.20063—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+4K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+4K252662UniBurNakanishi, Inc.20250—
+4K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+4K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+4K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+4K240340Surgical Drive System (Model: ES70, ES90, E8)Guangdong Jinme Medical Technology Co., Ltd.20240—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K241008Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece…Relign Corporation, Subsidiary of Zimmer Biomet20240—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…Stryker Leibinger GmbH & Co KG20240—
+4K233493Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece…Relign Corporation20231—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K170073LightMed Dental Laser SystemLightmed Dentaltechnology Corp.20170—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K073411LiteduoLight Instruments20081—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+4K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+5K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K193656SkyPulseFotona D.O.O.202011—
+5K173285Joule SystemSciton, Inc20185—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K132976AdvatxAdvalight Aps20141—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K093048D-Storm 810NM, D-Storm 980NMLight Instruments20100—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+5K081352Profile Multi-Platform SystemSciton, Inc2008112—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+6K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K250189AdvaTxAdvalight Aps20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K180508Joule SystemSciton, Inc20183—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—