Part 882 Subpart E—Neurological Surgical Devices
FDA submissions for Part 882 Subpart E—Neurological Surgical Devices in the Neurology (NE) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 882.4030–882.4950
CFR Part: 882
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| GXM | Anvil, Skull Plate | 882.4030 | 1 | 0 |
| HCD | Cannula, Ventricular | 882.4060 | 1 | 3 |
| HCA | Catheter, Ventricular | 882.4100 | 2 | 10 |
| NHC | Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents) | 882.4100 | 2 | 3 |
| PVM | Endoscopic Ventricular Catheter Placement Kit | 882.4100 | 2 | 0 |
| SDG | Brain Intraparenchymal Infusion Cannula | 882.4110 | 2 | 1 |
| HBN | Chair, Neurosurgical | 882.4125 | 1 | 4 |
| HBO | Clip, Scalp | 882.4150 | 2 | 10 |
| HCI | Applier, Aneurysm Clip | 882.4175 | 2 | 14 |
| HBS | Instrument, Clip Forming/Cutting | 882.4190 | 1 | 0 |
| NMN | Instrument, Clip, Forming/Cutting, Reprocessed | 882.4190 | 1 | 0 |
| HBQ | Instrument, Clip Removal | 882.4200 | 1 | 0 |
| HBR | Rack, Clip | 882.4215 | 1 | 1 |
| GXH | Device, Surgical, Cryogenic | 882.4250 | 2 | 23 |
| GZQ | Instrument, Dowel Cutting | 882.4275 | 2 | 1 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | 882.4300 | 2 | 17 |
| NLO | Drills, Burrs, Trephines And Accessories (Manual), Reprocessed | 882.4300 | 2 | 0 |
| HBF | Drills, Burrs, Trephines & Accessories (Compound, Powered) | 882.4305 | 2 | 18 |
| NLP | Drills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed | 882.4305 | 2 | 0 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 882.4310 | 2 | 65 |
| NLN | Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed | 882.4310 | 2 | 1 |
| PPT | Cranial Surgical Planning And Instrument Guides | 882.4310 | 2 | 4 |
| HBD | Handpiece (Brace), Drill | 882.4325 | 1 | 0 |
| HBC | Motor, Drill, Electric | 882.4360 | 2 | 26 |
| HBB | Motor, Drill, Pneumatic | 882.4370 | 2 | 27 |
| GXD | Generator, Lesion, Radiofrequency | 882.4400 | 2 | 37 |
| SGN | High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation | 882.4420 | 2 | 1 |
| HBM | Headrest, Neurosurgical | 882.4440 | 1 | 3 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 882.4460 | 2 | 50 |
| HBX | Instrument, Cranioplasty Material Forming | 882.4500 | 1 | 0 |
| GZX | Instrument, Microsurgical | 882.4525 | 1 | 13 |
| OJG | Neurological Tray | 882.4525 | 1 | 0 |
| HAO | Instrument, Surgical, Non-Powered | 882.4535 | 1 | 34 |
| GYK | Instrument, Shunt System Implantation | 882.4545 | 1 | 13 |
| PIY | Stainless Steel Instrument, Shunt System Implantation | 882.4545 | 1 | 0 |
| HAW | Neurological Stereotaxic Instrument | 882.4560 | 2 | 422 |
| OEW | Tracking, Soft Tissue, Intraoperative | 882.4560 | 2 | 4 |
| OJP | Orthopedic Computer Controlled Surgical System | 882.4560 | 2 | 4 |
| OLO | Orthopedic Stereotaxic Instrument | 882.4560 | 2 | 423 |
| ONA | Computer Assisted Hair Harvesting System | 882.4560 | 2 | 4 |
| ONN | Intraoperative Orthopedic Joint Assessment Aid | 882.4560 | 2 | 16 |
| ORR | Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri | 882.4560 | 2 | 4 |
| OSE | Patient Specific Manual Navigation System | 882.4560 | 2 | 0 |
| OSF | Patient Specific Manual Orthopedic Stereotaxic System | 882.4560 | 2 | 3 |
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | 882.4560 | 2 | 36 |
| QRI | Surgical Planning Software For Neurological Stereotaxic Instruments | 882.4560 | 2 | 1 |
| SBF | Orthopedic Augmented Reality | 882.4560 | 2 | 41 |
| SGE | Extracranial Positional System For A Transcranial Magnetic Stimulation System | 882.4560 | 2 | 1 |
| QLV | Field Generator Positioning Device | 882.4565 | 1 | 0 |
| GXE | Leukotome | 882.4600 | 1 | 1 |
| HAS | Needle, Neurosurgical Suture | 882.4650 | 1 | 0 |
| HBA | Neurosurgical Paddie | 882.4700 | 2 | 24 |
| GXI | Probe, Radiofrequency Lesion | 882.4725 | 2 | 66 |
| GXJ | Punch, Skull | 882.4750 | 1 | 0 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 882.4800 | 2 | 43 |
| HAE | Rongeur, Manual | 882.4840 | 2 | 36 |
| HAD | Rongeur, Powered | 882.4845 | 2 | 3 |
| GXL | Screwdriver, Skullplate | 882.4900 | 1 | 0 |
| QFX | Diagnostic Neurosurgical Microscope Filter | 882.4950 | 2 | 5 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K260011 | Foundation Surgical Navigated Lateral Disc Prep Instruments | Foundation Surgical Group, Inc. | Apr 16, 2026 |
| K253907 | Disposable Radiofrequency Cannula | ABBOTT MEDICAL | Apr 16, 2026 |
| K254158 | SPINEART Navigation Instrument System | Spineart SA | Apr 9, 2026 |
| K260240 | SYMPHONY Navigation Ready Instruments | Medos International SARL | Mar 27, 2026 |
| K260601 | REAL INTELLIGENCE CORI | Blue Belt Technologies, Inc. | Mar 26, 2026 |
| K253627 | Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) | Surgify Medical OY | Mar 26, 2026 |
| K253379 | Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. | Mar 26, 2026 |
| K252037 | CUVIS-joint (CJ150) | Curexo, Inc. | Mar 25, 2026 |
| K253604 | TiLink-L Navigation Instruments | SurGenTec, LLC | Mar 20, 2026 |
| K253444 | EUROPA Posterior Cervical Fusion Navigated Instruments | MiRus, LLC | Mar 18, 2026 |
| K260546 | Q Pedicle Instruments | K2m, Inc. | Mar 17, 2026 |
| K253395 | Stealth AXiS ENT clinical application | Medtronic Navigation, Inc. | Mar 16, 2026 |
| K253772 | Velocity Alpha MR High Speed Surgical Drill System | Adeor Medical AG | Mar 6, 2026 |
| K260010 | TMINI® Miniature Robotic System | THINK Surgical, Inc. | Mar 3, 2026 |
| K260222 | Mako Total Knee Application | Mako Surgical Corp. | Feb 25, 2026 |
| K252989 | POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set | Point Robotics MedTech, Inc. | Feb 20, 2026 |
| K254148 | VERTICALE GPS Instruments | Silony Medical GmbH | Feb 19, 2026 |
| K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor | Stryker Leibinger GmbH & Co KG | Feb 19, 2026 |
| K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) | Alphatec Spine, Inc. | Feb 19, 2026 |
| K251802 | STAR RF Ablation System | Merit Medical Systems, Inc. | Feb 13, 2026 |
| K253381 | Stealth AXiS Surgical System with Stealth AXiS Spine clinical application | Medtronic Navigation, Inc. | Feb 12, 2026 |
| K252873 | Q Interbody Instruments | K2m, Inc. | Feb 6, 2026 |
| K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories | Stryker Leibinger GmbH & Co KG | Feb 6, 2026 |
| K252058 | ROSA Knee System with UltraSound Imaging Platform (USIP) | Balmoral Medical, LLC | Feb 6, 2026 |
| K252087 | Navigation Module of the Cortium® System | Ulrich Medical USA, Inc. | Feb 3, 2026 |
| K252755 | POINT Kinguide Agile Robotic Arm Surgical Stereotactic System | Point Robotics MedTech, Inc. | Jan 23, 2026 |
| K251286 | Affirm 400 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | Jan 21, 2026 |
| K252962 | DYNAMIS Navigation System | Promethean Restorative, LLC | Jan 12, 2026 |
| K252847 | NextAR Hip Platform | Medacta International S.A. | Jan 9, 2026 |
| K253308 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models | Materialise NV | Jan 7, 2026 |
| K253661 | TMINI Miniature Robotic System | THINK Surgical, Inc. | Dec 22, 2025 |
| K252950 | Paradigm System | Proprio, Inc. | Dec 15, 2025 |
| K252841 | REAL INTELLIGENCE CORI XT (CORI XT) | Blue Belt Technologies, Inc. | Dec 5, 2025 |
| K251943 | Spineology Navigation Instruments | Spineology, Inc. | Dec 4, 2025 |
| K252696 | LEGACY | Phasor Health, LLC | Nov 21, 2025 |
| DEN250015 | Neurolyser XR (NXR100) | Fusmobile, Inc. | Nov 14, 2025 |
| K251314 | Rosa® Knee System | Orthosoft Inc. (d/b/a) Zimmer CAS | Nov 13, 2025 |
| K250815 | Hubly Drill (H100) | Hubly, Inc. | Nov 6, 2025 |
| K250423 | mb-FIX Cranial Stabilization Systems | Medical Bees GmbH | Nov 6, 2025 |
| K250599 | ExcelsiusGPS Instruments | Globus Medical, Inc. | Nov 5, 2025 |
| K252088 | Firebird SI Navigation System | Orthofix US, LLC | Oct 31, 2025 |
| K252060 | GREEN | Phasor Health, LLC | Oct 31, 2025 |
| K252742 | Navigated Instruments | Tyber Medical, LLC | Oct 28, 2025 |
| K250520 | OsteoCentric Navigated Instruments System | Osteocentric Technologies, Inc. | Oct 27, 2025 |
| K231897 | NeuroAlign software | Medivis, Inc. | Oct 21, 2025 |
| K251282 | StealthStation S8 Spine Software | Medtronic Navigation, Inc. | Oct 17, 2025 |
| K252544 | TMINI Miniature Robotic System | THINK Surgical, Inc. | Oct 10, 2025 |
| K251927 | Zeta Navigation System (ZNS131-US) | Zeta Surgical, Inc. | Oct 10, 2025 |
| K251639 | xvision Spine system | Augmedics, Ltd. | Oct 3, 2025 |
| K252054 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | Sep 29, 2025 |
| K251971 | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer | Stryker Instruments | Sep 25, 2025 |
| K252662 | UniBur | Nakanishi, Inc. | Sep 19, 2025 |
| K251780 | iGPS Navigation Instruments | SI-BONE, Inc. | Sep 15, 2025 |
| K252562 | Spine & Trauma Navigation Instruments | Brainlab AG | Sep 12, 2025 |
| K251316 | Mazor X System / Mazor X Stealth Edition | Mazor Robotics , Ltd. | Sep 11, 2025 |
| K252530 | OptiVu Shoulder | Mr Surgical Solutions, LLC | Sep 10, 2025 |
| K252524 | Quadsense (Quadsense and Quadsense Pro) | Eventum Orthopaedics, Ltd. | Sep 9, 2025 |
| K251317 | SOLOPASS 2.0 System | Intravent Medical Partners | Sep 5, 2025 |
| K251737 | NextAR(TM) Shoulder Platform | Medacta International S.A. | Sep 4, 2025 |
| K250893 | Ball Joint Guide Array (66295) | Bayer Medical Care, Inc. | Sep 4, 2025 |
| K250167 | Evolution Spine Navigation Instruments | Evolution Spine | Aug 18, 2025 |
| K251243 | OneRF Trigeminal Nerve Radiofrequency Probes | Neuroone Medical Technologies Corp. | Aug 15, 2025 |
| K252170 | OptiVu Shoulder | Mr Surgical Solutions, LLC | Aug 8, 2025 |
| K251247 | GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03) | Boston Scientific Neuromodulation Corporation | Aug 7, 2025 |
| K250477 | NextAR(TM) Spine | Medacta International S.A. | Jul 31, 2025 |
| K251060 | CORUS Navigation System-GX | Providence Medical Technology, Inc. | Jul 30, 2025 |
| K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) | Innovasis, Inc. | Jul 23, 2025 |
| K250505 | EZ-FIDUCIALS | Phasor Health, LLC | Jul 9, 2025 |
| K250108 | OptiVu Shoulder | Mr Surgical Solutions, LLC | Jul 9, 2025 |
| K241525 | ExcelsiusXR | Globus Medical, Inc. | Jul 8, 2025 |
| K250877 | TMINI Miniature Robotic System | THINK Surgical, Inc. | Jun 20, 2025 |
| K243053 | Navient Image Guided Navigation System (ENT) (955-NC-NC) | Claronav | Jun 20, 2025 |
| K242933 | SPINEART Navigation Instrument System | Spineart SA | Jun 18, 2025 |
| K242759 | Geister K-Rex rongeurs | Geister Medizin Technik GmbH | Jun 6, 2025 |
| K242464 | Stealth Spine Clamps; ModuLeX Shank Mounts | Medtronic Navigation, Inc. | Jun 5, 2025 |
| K251433 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) | Surgify Medical OY | Jun 4, 2025 |
| K250879 | Paradigm System | Proprio, Inc. | Jun 4, 2025 |
| K251315 | Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II | Remex Medical Corp. | May 29, 2025 |
| K242841 | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) | ABBOTT MEDICAL | May 27, 2025 |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac S | Brain Navi Biotechnology Co., Ltd. | May 23, 2025 |
| K250086 | OTS Hip | Ortoma AB | May 16, 2025 |
| K242569 | Mixed Reality Spine Navigation | Brainlab AG | May 16, 2025 |
| K250213 | OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) | Stryker Instruments | May 15, 2025 |
| K243419 | Altus Spine Navigation System | Altus Partners, LLC | May 8, 2025 |
| K250608 | Mako Total Knee Application (3.0); Hybrid Tip Pointer | Mako Surgical Corp. | Apr 25, 2025 |
| K243326 | Dynamis Robotic Surgical System | LEM Surgical AG | Apr 23, 2025 |
| K242806 | Medyssey Navigation System | Medyssey Co, Ltd. | Apr 16, 2025 |
| K250371 | cryoICE cryoXT cryoablation probe (cryoXT) | AtriCure, Inc. | Apr 10, 2025 |
| K243514 | Salvo® Robotic Navigation Instruments | Spine Wave, Inc. | Apr 3, 2025 |
| K243659 | FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments | SeaSpine Orthopedics Corporation | Apr 2, 2025 |
| K250182 | Innovasis Navigation Instruments | Innovasis, Inc. | Mar 24, 2025 |
| K243980 | ARVIS Surgical Navigation System | Kico Knee Innovation Company Pty Limited | Mar 21, 2025 |
| K243958 | Consolidated Operating Room Equipment (CORE) 2 Console | Stryker Instruments | Mar 21, 2025 |
| K243975 | Knee+ | Pixee Medical | Mar 20, 2025 |
| K242121 | mBôs (Monogram mBôs TKA System) | Monogram Orthopaedics, Inc. | Mar 14, 2025 |
| K250380 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1) | Surgify Medical OY | Mar 13, 2025 |
| K250255 | xvision Spine system | Augmedics, Ltd. | Mar 13, 2025 |
| K250374 | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R | Stryker Instruments | Mar 11, 2025 |
| K242914 | Op.n(TM) Navigation | Ecential Robotics | Mar 7, 2025 |
| K242890 | SPINEART Navigation Instrument System | Spineart SA | Mar 7, 2025 |
