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
+7K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+7K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+7K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+7K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+7K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)F Care Systems USA, LLC20250—
+7K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K252322SIros-X SystemGenesys Spine20250—
+7K250852CoolfaseAsterasys Co., Ltd.20250—
+7K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+7K251899E BlatorNew Deantronics Taiwan, Ltd.20250—
+7K252662UniBurNakanishi, Inc.20250—
+7K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)Venclose, Inc.20250—
+7K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+7K251327XERFLutronic Corporation202501
+7K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+7K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+7K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+7K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+7K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+7K242806Medyssey Navigation SystemMedyssey Co, Ltd.20250—
+7K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+7K242241SunnyShenB Co., Ltd.20250—
+7K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+7K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY202525
+7K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+7K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+7K242688Finiff SystemSkingrab Co., Ltd.20240—
+7K243073AnyPlus Navigated Instruments SystemGS Medical Co., Ltd.20240—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K240340Surgical Drive System (Model: ES70, ES90, E8)Guangdong Jinme Medical Technology Co., Ltd.20240—
+7K233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd.20240—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K240248Volnewmer™Classys, Inc.20241—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+7K233849BTL-499BTL Industries, Inc.20240—
+7K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+7K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+7K233604BTL-785SBTL Industries, Inc.20243—
+7K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+7K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+7K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+7K233024Alma HarmonyAlma Lasers, Inc.20241—
+7K23299210THERMATentech, Inc.20230—
+7K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+7K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+7K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+7K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+7K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+7K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+7K230663DensityJeisys Medical, Inc.20232—
+7K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+7K230087“POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc.20233—
+7K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+7K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+7K223511Excella Navigation InstrumentsInnovasis, Inc.20233—
+7K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K230308Alma HarmonyAlma Lasers, Inc.20232—
+7K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+7K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+7K223494CD Horizon Spinal SystemMedtronic202317—
+7K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+7K221989The OligioWontech Co., Ltd.20222—
+7K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+7K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+7K213761Joule diVa SystemSciton, Inc20220—
+7K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+7K221571InMode Multi-systemInMode, Ltd.20222—
+7K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+7K221244CD Horizon™ Spinal SystemMedtronic202220—
+7K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+7K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+7K220291NEXXT SPINE NAVIGATION SystemNexxt Spine, LLC20220—
+7K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+7K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+7K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+7K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+7K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+7K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+7K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+7K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+7K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+7K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH202114
+7K193070VIVACE Electrosurgical DeviceShenB Co., Ltd.20214—
+7K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+7K203816DeGen Navigated InstrumentationDegen Medical20211—
+7K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+7K203054FlexSysGme German Medical Engineering GmbH20210—
+7K202956Erisma LP Navigated InstrumentsClariance, Sas20210—
+7K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+7K202415VirtueRFShenB Co., Ltd.20213—
+7K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+7K203291CD Horizon Spinal System InstrumentsMedtronic Sofamor Danek USA, Inc.202035—
+7K192406AveCure BT Microwave Ablation SystemMedwaves, Inc.20200—