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
+8K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+8K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+8K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+8K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+8K243488Vmat ProTermosalud20250—
+8K240311JETT Medical IICompex, Spol, S.R.O.20250—
+8K243067The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company)20250—
+8K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+8K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+8K242532BTL-785BNF-EBTL Industries, Inc.20241—
+8K240897CellinewVIOL Co., Ltd.20240—
+8K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+8K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+8K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+8K231948MediyagMedicreations, LLC20240—
+8K241895Cannulated PsiFGuardSpineguard20240—
+8K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+8K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+8K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+8K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+8K241130“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Point Robotics MedTech, Inc.20242—
+8K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+8K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…Stryker Sustainability Solutions20240—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K233255CROSSNAV Navigation Enabled InstrumentsDePuy Synthes20242—
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K240963Spinal SystemTeslake, Inc.20240—
+8K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+8K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+8K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+8K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+8K240392JAZZ Spinal SystemImplanet20241—
+8K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+8K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+8K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+8K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+8K234057NirvanaEl.En S.P.A.20240—
+8K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+8K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+8K232301Define RF Microneedling SystemAesthetic Management Partners20240—
+8K233830OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20241—
+8K240313Oligio XWontech Co., Ltd.20241—
+8K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…Stryker Sustainability Solutions20241—
+8K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+8K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+8K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+8K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+8K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+8K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+8K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+8K231527TriALTIS Navigation Enabled InstrumentsMedos International Sàrl20233—
+8K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+8K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+8K223303Spinery™ RF Ablation SystemAxon Spine Medical System20230—
+8K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+8K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+8K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+8K230968VYBE RF Electrosurgical SystemShenB Co., Ltd.20231—
+8K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+8K231184CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20230—
+8K231229S-COMP Reform® POCT Navigation InstrumentsPrecision Spine, Inc.20230—
+8K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+8K221865BTL-094BTL Industries, Inc.20230—
+8K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+8K213815SiJoin®T3Vgi Medical, Inc.20230—
+8K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+8K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+8K210166Omnispec ED1000Medispec, Ltd.20230—
+8K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+8K221873NeoGen PSR SystemEnergist Limited20230—
+8K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+8K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+8K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+8K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+8K22079410PLTentech Co., Ltd.20220—
+8K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+8K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+8K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+8K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceStryker Corporation20222—
+8K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+8K212790XLase PlusBiotec Italia, Srl20220—
+8K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+8K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+8K213612Sylfirm XVIOL Co., Ltd.20221—
+8K210084SilkroHironic Co., Ltd.20223—
+8K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+8K210183Waterlase iPLusBiolase, Inc.20220—
+8K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+8K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+8K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+8K213918DeGen Navigated InstrumentationDegen Medical20220—
+8K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+8K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—