510(k) submissions
Filtered by Navigation System · showing 51–100 of 156
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K242914 | Op.n(TM) NavigationSpine Surgery | Ecential RoboticsFrance | Software Navigation | Class 2 | 2025-03-07 |
| K242890 | SPINEART Navigation Instrument SystemSpine Surgery | Spineart SASwitzerland | Stereotactic Surgery | Class 2 | 2025-03-07 |
| K243258 | Paradigm SystemSpine Surgery | Proprio, Inc.United States | Image Guided Surgery | Class 2 | 2025-02-21 |
| K243387 | GYDER® Hip SystemNavigation System | Gyder Surgical Pty, Ltd.Australia | Stereotactic Surgery | Class 2 | 2025-01-29 |
| K243814 | NuVasive Pulse SystemSpine Surgery | Globus Medical, Inc.United States | Image Guided Surgery | Class 2 | 2025-01-10 |
| K243671 | ExcelsiusGPS® InstrumentsSpine Surgery | Globus Medical, Inc.United States | Software Navigation | Class 2 | 2024-12-20 |
| K243560 | Remex Spine Surgery Navigation InstrumentSpine Surgery | Remex Medical Corp.Taiwan | Image Guided Surgery | Class 2 | 2024-12-13 |
| K243073 | AnyPlus Navigated Instruments SystemSpine Surgery | GS Medical Co., Ltd.Korea, Republic of | Image Guided Surgery | Class 2 | 2024-12-06 |
| K242373 | Mako Shoulder Application (1.0)Other | Mako Surgical Corp.United States | Stereotactic Surgery | Class 2 | 2024-11-07 |
| K240160 | EGPS Navigated InstrumentsSpine Surgery | Astura MedicalUnited States | Robotic Navigation | Class 2 | 2024-10-17 |
| K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysSpine Surgery | Medos International SARLSwitzerland | Software Navigation | Class 2 | 2024-09-16 |
| K241517 | Q Guidance System; Mako Spine System;Spine Surgery | Stryker Leibinger GmbH & Co KGGermany | Software Navigation | Class 2 | 2024-08-27 |
| K242009 | 360CAS KneeKnee Surgery | Kico Knee Innovation Company Pty, Ltd.Australia | Image Guided Surgery | Class 2 | 2024-08-08 |
| K241644 | SPINEART Navigation Instrument SystemSpine Surgery | Spineart SASwitzerland | Image Guided Surgery | Class 2 | 2024-08-07 |
| K233725 | Spine Navigation SystemSpine Surgery | Medivis, Inc.United States | Stereotactic Surgery | Class 2 | 2024-07-26 |
| K241171 | Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting AccessoriesSpine Surgery | Stryker Leibinger GmbH & Co KGGermany | Software Navigation | Class 2 | 2024-07-25 |
| K241130 | “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Spine Surgery | Point Robotics MedTech, Inc.Taiwan | Software Navigation | Class 2 | 2024-07-24 |
| K241031 | TMINI Miniature Robotic System (TMINI 1.1)Knee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2024-07-12 |
| K241625 | Anatase Navi Disposable InstrumentSpine Surgery | Remex Medical Corp.Taiwan | Image Guided Surgery | Class 2 | 2024-07-05 |
| K233256 | Robotic Integration InstrumentsSpine Surgery | DePuy SynthesSwitzerland | Robotic Navigation | Class 2 | 2024-06-17 |
| K233255 | CROSSNAV Navigation Enabled InstrumentsSpine Surgery | DePuy SynthesSwitzerland | Image Guided Surgery | Class 2 | 2024-06-17 |
| K241082 | INNOVERSE Navigation InstrumentsSpine Surgery | Innosys Co., Ltd.Korea, Republic of | Stereotactic Surgery | Class 2 | 2024-06-14 |
| K240721 | ExcelsiusFlex™Knee Surgery | Globus Medical, Inc.United States | Software Navigation | Class 2 | 2024-06-14 |
| K233254 | TELIGEN System Navigation Ready InstrumentsSpine Surgery | DePuy SynthesSwitzerland | Stereotactic Surgery | Class 2 | 2024-06-14 |
| K233228 | Spine Navigation and Robotic-Assistance DeviceSpine Surgery | Ecential RoboticsFrance | Robotic Navigation | Class 2 | 2024-06-14 |
| K241011 | Mako Total Knee ApplicationKnee Surgery | Mako Surgical Corp.United States | Stereotactic Surgery | Class 2 | 2024-06-11 |
| K240951 | Invictus Robotic Navigation InstrumentsSpine Surgery | Alphatec Spine, Inc.United States | Robotic Navigation | Class 2 | 2024-06-06 |
| K240662 | Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary HandpieceSpine Surgery | Stryker Leibinger GmbH & Co KGGermany | Software Navigation | Class 2 | 2024-06-06 |
| K240211 | VELYS Robotic-Assisted SolutionKnee Surgery | Depuy Ireland UCIreland | Stereotactic Surgery | Class 2 | 2024-06-05 |
| K240701 | Drill Guide; Drill Bit; Spine & Trauma NavigationSpine Surgery | Brainlab AGUnited States | Image Guided Surgery | Class 2 | 2024-05-23 |
| K240625 | CORUS Navigation Access SystemSpine Surgery | Providence Medical Technology, Inc.United States | Image Guided Surgery | Class 2 | 2024-05-03 |
| K233513 | Remex Spine Surgery Navigation System IISpine Surgery | Remex Medical Corp.Taiwan | Image Guided Surgery | Class 2 | 2024-05-01 |
| K240568 | DuraPro™ Oscillating SystemSpine Surgery | Globus Medical, Inc.United States | Robotic Navigation | Class 2 | 2024-04-29 |
| K240647 | Virage® Navigation SystemSpine Surgery | Zimvie Spine (Zimmer Biomet Spine, Inc.)United States | Software Navigation | Class 2 | 2024-04-05 |
| K233595 | Genesys Spine Sacroiliac Joint Fusion System with NavigationSpine Surgery | Genesys SpineUnited States | Software Navigation | Class 2 | 2024-03-29 |
| K234047 | Automatic RegistrationNavigation System | Brainlab AGUnited States | Image Guided Surgery | Class 2 | 2024-03-20 |
| K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance SystemKnee Surgery | Stryker Leibinger GmbH & Co KGGermany | Software Navigation | Class 2 | 2024-03-14 |
| K232140 | OTS HipNavigation System | Ortoma ABSweden | Image Guided Surgery | Class 2 | 2024-03-11 |
| K230195 | Neo ADVISE softwareSpine Surgery | Comerge AGSwitzerland | Software Navigation | Class 2 | 2024-03-08 |
| K232800 | Navigation Tracking InstrumentsSpine Surgery | SI-BONE, Inc.United States | Stereotactic Surgery | Class 2 | 2024-02-23 |
| K233199 | ROSA® Shoulder SystemOther | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2024-02-21 |
| K233299 | ExactechGPS® SystemKnee Surgery | Blue OrthoFrance | Stereotactic Surgery | Class 2 | 2024-01-26 |
| K233227 | VELYS™ Robotic-Assisted SolutionKnee Surgery | Depuy Ireland UCIreland | Stereotactic Surgery | Class 2 | 2023-12-14 |
| K232572 | Kalitec Navigated Instrument SystemSpine Surgery | Kalitec Direct, LLC Doing Business AS Kalitec MedicalUnited States | Image Guided Surgery | Class 2 | 2023-12-13 |
| K230700 | RIWOtrack Navigation SystemSpine Surgery | Fiagon GmbHUnited States | Stereotactic Surgery | Class 2 | 2023-11-20 |
| K233443 | Vital™ Navigation SystemSpine Surgery | Zimvie Spine (Zimmer Biomet Spine, Inc.)United States | Software Navigation | Class 2 | 2023-11-16 |
| K232521 | ExactechGPS® Total Ankle ApplicationNavigation System | Blue OrthoFrance | Software Navigation | Class 2 | 2023-11-16 |
| K231494 | CoreLink Robotic Navigation InstrumentsSpine Surgery | Corelink, LLCUnited States | Robotic Navigation | Class 2 | 2023-10-27 |
| K232044 | Invictus Robotic Navigation InstrumentsSpine Surgery | Alphatec Spine, Inc.United States | Robotic Navigation | Class 2 | 2023-10-06 |
| K231527 | TriALTIS Navigation Enabled InstrumentsSpine Surgery | Medos International SARLSwitzerland | Image Guided Surgery | Class 2 | 2023-09-29 |