510(k) Report

Devices descending from K952681

1,700 later devices reach Stryker Hummer II Microdebrider System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K211562Virtue RFShenB Co., Ltd.20212—
+8K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+8K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+8K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+8K212678Viveve System, Viveve 2.0 SystemViveve Medical, Inc.20211—
+8K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+8K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+8K203728DarwinLuvo Medical Technologies, Inc.20211—
+8K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+8K211596CD Horizon Spinal SystemMedtronic20213—
+8K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+8K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+8K211323ASTRA Spine SystemSpinecraft, LLC202112—
+8K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+8K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+8K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+8K202955Contour Light CL-100Contour Research, LLC20218—
+8K210306GII Spinal Fixation SystemColigne AG20210—
+8K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+8K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+8K210472SPINEART Navigation Instrument SystemSpineart20215—
+8K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+8K203299CellFX SystemPulse Biosciences, Inc.20214—
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K201685PotenzaJeisys Medical, Inc.20219—
+8K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+8K201735PlaDuo SystemShenB Co., Ltd.20203—
+8K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+8K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+8K192275invisa-RED ELITEIR Technology, LLC20201—
+8K201006K2M Navigation InstrumentsK2m, Inc.20200—
+8K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+8K201327NavLock TrackersMedtronic Navigation20202—
+8K200616E>EyeCE-Swin20200—
+8K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+8K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+8K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+8K193367elysion-proHigh Technology Products S.L.U20203—
+8K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+8K193611Viveve 2.0 SystemViveve Medical, Inc.20202—
+8K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+8K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+8K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+8K192728AgnesAgnes Medical Co., Ltd.20196—
+8K192526Spine Wave Navigated InstrumentsSpine Wave, Inc.20190—
+8K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+8K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+8K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+8K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+8K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+8K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+8K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl20192—
+8K182721Choice Spine Navigation SystemChoicespine, LP20192—
+8K182104NavLock Trackers, Robotic Reference FrameMedtronic Navigation201831
+8K182365TempSure SystemCynosure, Inc.201815—
+8K180338CellulizeWard Photonics, LLC20182—
+8K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+8K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+8K181659Avologi ENEOPremier North America, Inc.20184—
+8K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+8K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+8K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+8K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+8K180508Joule SystemSciton, Inc20183—
+8K181111Navigated INFINITY InstrumentsMedtronic Sofamor Danek USA, Inc.20182—
+8K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+8K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+8K180320dpl IIa PanelLed Technologies, Inc.201814—
+8K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+8K173338Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc.201815—
+8K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+8K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+8K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+8K172111Vevazz LEDVevazz, LLC20170—
+8K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+8K171702Exciplex308nmClarteis20175—
+8K172413MT ONEM&T S.R.L.20175—
+8K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+8K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+8K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+8K171321K2M Navigation InstrumentsK2m201711
+8K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+8K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+8K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+8K163196ACTION II Laser SystemLutronic Corporation20170—
+8K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+8K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+8K163415SlimShape SystemSyneron Medical, Ltd.201714—
+8K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+8K162784Silk'n HSTHome Skinovations, Ltd.20171—
+8K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+8K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+8K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.20171—
+8K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+8K162512truSculptCutera, Inc.20165—
+8K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+8K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+8K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—