Review Panel
Neurology FDA 510(k) Clearances & Devices
- Cleared Devices
- 6,130
- Product Codes (page)
- 40
- Latest Decision
- 2022-04-22
Clearances · page 10 of 62
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K213708 | ROSA® Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | OLO | Class II | 2022-04-22 |
| K220152 | TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) | Hong Qiangxing (Shenzhen) Electronics Limited | NUH | Class II | 2022-04-19 |
| K213930 | Brainlab Elements Guide XT, Guide 3.0 | Brainlab AG | QQC | Class II | 2022-04-19 |
| K212377 | Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 | Ningbo Medkinetic Medical Device Co., Ltd. | NUH | Class II | 2022-04-15 |
| K220459 | Mako Total Knee Application | Mako Surgical Corp. | OLO | Class II | 2022-04-15 |
| K212245 | Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning | Brainlab AG | OLO | Class II | 2022-04-13 |
| K214040 | ClearPoint Array System (version 1.1) | ClearPoint Neuro, Inc. | HAW | Class II | 2022-04-12 |
| K210109 | visor2 system | Eemagine Medical Imaging Solutions GmbH | HAW | Class II | 2022-04-08 |
| K220625 | ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System | Remed Co., Ltd. | OBP | Class II | 2022-04-06 |
| K220005 | TENS & PMS Unit | Shenzhen Yuehua Xinsen Technology Co., Ltd. | NUH | Class II | 2022-04-01 |
| K212184 | TENS and EMS Stimulation (OTC) | Changsha Yuwen Medical Equipment Co., Ltd. | NUH | Class II | 2022-04-01 |
| K220291 | NEXXT SPINE NAVIGATION System | Nexxt Spine, LLC | OLO | Class II | 2022-03-31 |
| K220255 | REAL INTELLIGENCE CORI | Blue Belt Technologies, Inc. | OLO | Class II | 2022-03-29 |
| DEN200042 | BrainTemp Neonate System (BTNeo System) | Brain Temp, Inc. | QSL | Class II | 2022-03-29 |
| K211887 | Personal Kinetigraph (PKG) System Gen 2 Plus | Gkc Manufacturing Pty, Ltd. | GYD | Class II | 2022-03-11 |
| K213836 | Intracept Intraosseous Nerve Ablation System | Relievant Medsystems, Inc. | GXI | Class II | 2022-03-11 |
| K213751 | NextAR TKA Platform My Knee PPS | Medacta International S.A. | SBF | Class II | 2022-03-10 |
| K213849 | SafeOp 2: Neural Informatix System | Alphatec Spine, Inc. | GWF | Class II | 2022-03-09 |
| K213741 | TENS & EMS DEVICE (Model: FM-B2403A) | Shenzhen Jian Feng Electronic Technology Co., Ltd. | NUH | Class II | 2022-03-08 |
| K212723 | BTL-995-rTMS | BTL Industries, Inc. | OBP | Class II | 2022-03-04 |
| K212149 | MyndMove 2.0 | Myndtec, Inc. | GZI | Class II | 2022-03-03 |
| K213835 | TENS & EMS Device | Shenzhen Jian Feng Electronic Technology Co., Ltd. | NUH | Class II | 2022-03-03 |
| K211183 | Sugita AVM Microclips | Mizuho America, Inc. | HCH | Class II | 2022-03-02 |
| K203113 | Masimo SedLine Sedation Monitor and Accessories | Masimo Corporation | OLW | Class II | 2022-02-25 |
| K214100 | Luminice | Premier North America, Inc. | NFO | Class II | 2022-02-24 |
| K211965 | StimRouter Neuromodulation System | Bioness, Inc. | GZF | Class II | 2022-02-23 |
| K213091 | Well-Life TENS/EMS/Heating Stimulator | Well-Life Healthcare Limited | NUH | Class II | 2022-02-19 |
| K220150 | TENS & PMS (Model: SM9126) | Hong Qiangxing (Shenzhen) Electronics Limited | NUH | Class II | 2022-02-17 |
| K213622 | Cionic Neural Sleeve NS-100 | Cionic | GZI | Class II | 2022-02-14 |
| K202234 | NervAlign Nerve Cuff | Renerve, Ltd. | JXI | Class II | 2022-02-10 |
| K214011 | Catalyft PL Expandable Interbody System Navigated Instruments, Anteralign TL Spinal System with Titan nanoLOCK Surface Technology Navigated Instruments, and CD Horizon Solera Voyager Spinal System Navigated, Guided, and Powered Drivers | Medtronic Sofamor Danek USA, Inc. | OLO | Class II | 2022-02-09 |
| K213918 | DeGen Navigated Instrumentation | Degen Medical | OLO | Class II | 2022-02-09 |
| K213188 | Primary Relief | Dyansys, Inc. | NHI | Class II | 2022-01-31 |
| K212943 | SyntheCel Dura Repair | Synthes (USA) Products, LLC | GXQ | Class II | 2022-01-28 |
| K210360 | Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models) | Osteonic Co., Ltd. | GWO | Class II | 2022-01-27 |
| K203293 | Abbott Medical Grounding Pad, model RF-DGP-IS | ABBOTT MEDICAL | GXD | Class II | 2022-01-21 |
| K214059 | CoreLink Navigation Instruments | Corelink, LLC | OLO | Class II | 2022-01-19 |
| K213033 | iASSIST Knee System | Orthosoft D/B/A Zimmer Cas | OLO | Class II | 2022-01-14 |
| K211254 | ARAI Surgical Navigation System | Surgalign Spine Technologies | SBF | Class II | 2022-01-14 |
| K213380 | 360CAS | Kico Knee Innovation Company Pty Limited | OLO | Class II | 2022-01-11 |
| K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | GWF | Class II | 2022-01-07 |
| K213720 | Vital Navigation System | Zimvie (Zimmer Biomet Spine, Inc.) | OLO | Class II | 2022-01-07 |
| K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | Blue Ortho | OLO | Class II | 2022-01-06 |
| K213879 | Self-adhesive Electrode | Bozhou Rongjian Medical Appliance Co., Ltd. | GXY | Class II | 2022-01-05 |
| K211263 | Intrelief | Easymed Instruments Co., Ltd. | NUH | Class II | 2021-12-30 |
| K212088 | Integrity Implants Navigated Instruments | Integrity Implants, Inc. | OLO | Class II | 2021-12-23 |
| K213208 | Twist Drills | Biomet Microfixation | HBE | Class II | 2021-12-23 |
| K212397 | StealthStation S8 Cranial v2.0 | Medtronic Navigation | HAW | Class II | 2021-12-22 |
| K212310 | EyeBOX (Model EBX-4) | Oculogica, Inc. | QEA | Class II | 2021-12-22 |
| K212285 | Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android) | Oriental Inspiration Limited | NUH | Class II | 2021-12-22 |
| K210099 | Meticuly Patient-Specific Titanium Mesh Implant | Meticuly Co., Ltd. | GXN | Class II | 2021-12-21 |
| K212859 | First Relief | Dyansys, Inc. | NHI | Class II | 2021-12-20 |
| K210223 | Transcutaneous Electrical Nerve Stimulator | Top-Rank Health Care Co., Ltd. | NUH | Class II | 2021-12-15 |
| K212918 | Heat StimPlus | Famidoc Technology Co., Ltd. | NUH | Class II | 2021-12-13 |
| K211572 | Aesculap Slim Clip Applier | Aesculap, Inc. | HCI | Class II | 2021-12-13 |
| K213543 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health | Neuronetics, Inc. | OBP | Class II | 2021-12-10 |
| K201435 | Molecular Flow Simulations | Therataxis, LLC | HAW | Class II | 2021-12-03 |
| K211452 | Encevis | Austrian Institute of Technology GmbH | OMB | Class II | 2021-12-02 |
| K212326 | AC Cream - Conductive paste | Spes Medica Srl | GYB | Class II | 2021-12-01 |
| K202537 | ALTMS Magnetic Stimulation Therapy System | Remed Co., Ltd. | OBP | Class II | 2021-11-26 |
| K213454 | Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm | Medtronic Powered Surgical Solutions | HBE | Class II | 2021-11-23 |
| K212989 | Low-frequency Stimulator (Model: AST-645, AST-646) | Shenzhen Osto Technology Co., Ltd. | NUH | Class II | 2021-11-22 |
| K202087 | DIXI Medical Microdeep Micro-Macro Depth Electrodes | Dixi Medical | GZL | Class II | 2021-11-18 |
| DEN210014 | EaseVRx | Appliedvr, Inc. | QRA | Class II | 2021-11-16 |
| K212455 | InZone Detachment System | Stryker Neurovascular | HCG | Class II | 2021-11-16 |
| K210383 | Wrap Accessory Electrodes | Hi-Dow International, Inc. | GXY | Class II | 2021-11-12 |
| K210989 | Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System | Brainlab AG | HAW | Class II | 2021-11-12 |
| K202671 | DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) | Guangzhou Xinbo Electronic Co., Ltd. | NUH | Class II | 2021-11-12 |
| K211315 | Comby EEG Caps | Pamel D.O.O | GXY | Class II | 2021-11-09 |
| K212787 | GT5 conductive & abrasive gel | Wuhan Greentek Pty , Ltd. | GYB | Class II | 2021-11-08 |
| K202110 | MStim Drop Model: LGT-233 | Guangzhou Longest Science & Technology Co., Ltd. | GZI | Class II | 2021-11-05 |
| K210859 | NextAR Spine Platform | Medacta International S.A. | SBF | Class II | 2021-11-05 |
| K211055 | Microcurrent device (Model: HBR2-1) | Shenzhen DJ Medical Equipment Co., Ltd. | NFO | Class II | 2021-11-05 |
| K211971 | Drug Relief v1 | Dyansys, Inc. | PZR | Class II | 2021-11-05 |
| K212537 | REAL INTELLIGENCE CORI (CORI) | Blue Belt Technologies, Inc. | OLO | Class II | 2021-11-03 |
| K211544 | Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization | Brainlab AG | HAW | Class II | 2021-11-03 |
| K202120 | P300 Attachment | Nakanishi, Inc. | HBE | Class II | 2021-10-22 |
| K211403 | HIVOX OTC Electrical Stimulator, FT610-B | Hivox Biotek, Inc. | NUH | Class II | 2021-10-15 |
| K211147 | ALGO 7i | Path Medical GmbH | GWJ | Class II | 2021-10-14 |
| K211801 | SPRINT PNS System | Spr Therapeutics, Inc. | NHI | Class II | 2021-10-13 |
| K212825 | CoreLink Navigation Instruments | Corelink, LLC | OLO | Class II | 2021-10-13 |
| K201989 | B4C System | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | GWM | Class II | 2021-10-08 |
| K212191 | Adhesive Electrodes | Voncare Medical Device Co., Ltd. | GXY | Class II | 2021-10-06 |
| K203288 | Cala Trio | Cala Health, Inc. | QBC | Class II | 2021-10-05 |
| K200558 | Smart Neck Stimulator | Guandong Skg Intelligent Technology Co., Ltd. | NUH | Class II | 2021-10-04 |
| K201931 | Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) | Dixi Medical | GYC | Class II | 2021-10-02 |
| K202927 | EYE-SYNC | Syncthink, Inc. | QEA | Class II | 2021-10-02 |
| K212414 | OSSDSIGN Cranial PSI | Ossdsign AB | PJN | Class II | 2021-10-01 |
| K212238 | TheraFace Microcurrent | Theragun, Inc. | NFO | Class II | 2021-09-29 |
| K212028 | Dark Star Navigation Instrument System | Republic Spine, LLC | OLO | Class II | 2021-09-27 |
| K212342 | ZIIP+ Device | Ziip, Inc. | NFO | Class II | 2021-09-23 |
| K211974 | LED PHOTIC System | Micromed S.P.A. | GWE | Class II | 2021-09-23 |
| K212641 | StrataMR II Valves and Shunts | Medtronic Neurosurgery | JXG | Class II | 2021-09-16 |
| K211389 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation | Magstim Company, Ltd. | OBP | Class II | 2021-09-14 |
| K211334 | Iovera System | Pacira Pharmaceuticals, Inc. | GXH | Class II | 2021-09-10 |
| K211856 | gammaCore Sapphire | Electrocore, Inc. | PKR | Class II | 2021-09-10 |
| K212058 | Longeviti ClearFit OTS Cranial Implants | Longeviti Neuro Solutions, LLC | GXN | Class II | 2021-09-08 |
| K211736 | Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) | Shenzhen Osto Technology Company Limited | NUH | Class II | 2021-09-05 |
| K203625 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | HCG | Class II | 2021-09-01 |
| K211367 | Evo sEEG System | Neuroone Medical Technologies Corp. | GZL | Class II | 2021-09-01 |
6,130 clearances in the Neurology panel. Data: openFDA.