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
+7K200472Viveve SystemViveve Medical, Inc.20202—
+7K202771CD Horizon Spinal SystemMedtronic202021—
+7K200845Navigation Module of the Momentum SystemUlrich Medical USA20200—
+7K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+7K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+7K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+7K200791Navigation Enabled IntrumentsMedos International SARL20205—
+7K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+7K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+7K200095Streamline Navigated InstrumentsPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.202004
+7K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC20204—
+7K192856MT OneM&T S.R.L.20202—
+7K200185Sylfirm XVIOL Co., Ltd.20202—
+7K193656SkyPulseFotona D.O.O.202011—
+7K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+7K192545PotenzaJeisys Medical Incorporated202020—
+7K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems20200—
+7K183284INTRAcel RF Microneedle SystemJeisys Medical, Inc.20200—
+7K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+7K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+7K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+7K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K191693BC-5Reveallux, Corp20190—
+7K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+7K181606Precision Spine Navigation InstrumentationPrecision Spine, Inc.20193—
+7K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+7K183708Poly ClearMedtek Skincare, LLC201922—
+7K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+7K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+7K190422Viveve System 2.0Viveve Medical20194—
+7K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+7K183381Navigation Enabled InstrumentsStryker20191—
+7K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+7K182497OsteoCool RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20195—
+7K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+7K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+7K182121CD HORIZON Spinal System Instruments for use with MAZOR X Stealth EditionMedtronic Sofamor Danek USA, Inc.201841—
+7K181596Spine Wave Navigated InstrumentsSpine Wave, Inc.20181—
+7K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—
+7K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+7K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+7K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+7K172517SeaSpine Navigation SystemSeaSpine Orthopedics Corporation2018601
+7K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+7K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+7K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+7K172115Navigated Instrument SystemOrthofix, Inc.20184—
+7K173285Joule SystemSciton, Inc20185—
+7K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+7K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+7K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+7K172096FraxisIlooda Co,., Ltd.20172—
+7K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+7K171267NavLock TrackersMedtronic Navigation201741
+7K170325Secret RFIlooda Co,., Ltd.201710—
+7K162921Navigated Instrument SystemOrthofix, Inc.20175—
+7K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+7K163548ENSEAL X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20170—
+7K153587Taps for Resorbable ScrewsSynthes (USA) Products, LLC20170—
+7K160469AGNESGowoonsesang Cosmetics Co., Ltd.20179—
+7K163373PK AIMGyrus Acmi, Inc.20161—
+7K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+7K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+7K160880Photonica ProfessionalWard Photonics, LLC20166—
+7K160075Accent XLAlma Lasers, Inc.20160—
+7K153603Alphatec Navigation InstrumentsAlphatec Spine, Inc.201679—
+7K153229SuperbiumBios S.R.L.20162—
+7K153081Clear Bi-LightMichael Todd, LP201646—
+7K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+7K134036Wavetronic 5000 Digital HF Surgical UnitLoktal Medical Electronics Ind. Com. Ltda- Epp20150—
+7K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+7K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+7K140386Lumina 24Rogers Sciences, Inc.20150—
+7K141237Harmony LiteAlma, Inc.20154—
+7K143109XP300BTL Industries, Inc.20150—
+7K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+7K143628Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc.2015206—
+7K142860Lumenis M22 SystemLumenis, Ltd.2015381
+7K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+7K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+7K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+7K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+7K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+7K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+7K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+7K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+7K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+7K132976AdvatxAdvalight Aps20141—
+7K124064Young AgainEspansione Marketing S.P.A20131—
+7K132297EM Sinus Dilation SystemMedtronic Xomed, Inc.20135—
+7K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+7K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+7K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+7K120510TranscendSyneron Medical, Ltd.201318—
+7K123366Surgitron 4.0 Dual RF S5-IecEllman International, Inc.2013161
+7K122200A3F FrationalPollogen, Ltd.20130—
+7K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+7K121435Silkn BlueHome Skinovations, Ltd.2013125—
+7K122237Biophotas LifelightBiophotas, Inc.201371—