510(k) submissions
Filtered by Image Guided Surgery · showing 1–50 of 51
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K260329 | Ion-C Navigation InstrumentsSpine Surgery | SurGenTec, LLCUnited States | Image Guided Surgery | Class 2 | 2026-05-22 |
| K260240 | SYMPHONY Navigation Ready InstrumentsSpine Surgery | Medos International SARLSwitzerland | Image Guided Surgery | Class 2 | 2026-03-27 |
| K252989 | “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetSpine Surgery | Point Robotics MedTech, Inc.Taiwan | Image Guided Surgery | Class 2 | 2026-02-20 |
| K253381 | Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationSpine Surgery | Medtronic Navigation, Inc.United States | Image Guided Surgery | Class 2 | 2026-02-12 |
| K252087 | Navigation Module of the Cortium® SystemSpine Surgery | Ulrich Medical USA, Inc.United States | Image Guided Surgery | Class 2 | 2026-02-03 |
| K252962 | DYNAMIS™ Navigation SystemSpine Surgery | Promethean Restorative, LLCUnited States | Image Guided Surgery | Class 2 | 2026-01-12 |
| K252950 | Paradigm SystemSpine Surgery | Proprio, Inc.United States | Image Guided Surgery | Class 2 | 2025-12-15 |
| K250520 | OsteoCentric Navigated Instruments SystemSpine Surgery | Osteocentric Technologies, Inc.United States | Image Guided Surgery | Class 2 | 2025-10-27 |
| K252562 | Spine & Trauma Navigation InstrumentsSpine Surgery | Brainlab AGUnited States | Image Guided Surgery | Class 2 | 2025-09-12 |
| K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)Spine Surgery | Innovasis, Inc.United States | Image Guided Surgery | Class 2 | 2025-07-23 |
| K250879 | Paradigm SystemSpine Surgery | Proprio, Inc.United States | Image Guided Surgery | Class 2 | 2025-06-04 |
| K251315 | Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System IISpine Surgery | Remex Medical Corp.Taiwan | Image Guided Surgery | Class 2 | 2025-05-29 |
| K250086 | OTS HipNavigation System | Ortoma ABSweden | Image Guided Surgery | Class 2 | 2025-05-16 |
| K243419 | Altus Spine Navigation SystemSpine Surgery | Altus Partners, LLCUnited States | Image Guided Surgery | Class 2 | 2025-05-08 |
| K242806 | Medyssey Navigation SystemSpine Surgery | Medyssey Co, Ltd.Korea, Republic of | Image Guided Surgery | Class 2 | 2025-04-16 |
| K243258 | Paradigm SystemSpine Surgery | Proprio, Inc.United States | Image Guided Surgery | Class 2 | 2025-02-21 |
| K243814 | NuVasive Pulse SystemSpine Surgery | Globus Medical, Inc.United States | Image Guided Surgery | Class 2 | 2025-01-10 |
| 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 |
| 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 |
| K241625 | Anatase Navi Disposable InstrumentSpine Surgery | Remex Medical Corp.Taiwan | Image Guided Surgery | Class 2 | 2024-07-05 |
| K233255 | CROSSNAV Navigation Enabled InstrumentsSpine Surgery | DePuy SynthesSwitzerland | Image Guided Surgery | Class 2 | 2024-06-17 |
| 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 |
| K234047 | Automatic RegistrationNavigation System | Brainlab AGUnited States | Image Guided Surgery | Class 2 | 2024-03-20 |
| K232140 | OTS HipNavigation System | Ortoma ABSweden | Image Guided Surgery | Class 2 | 2024-03-11 |
| K232572 | Kalitec Navigated Instrument SystemSpine Surgery | Kalitec Direct, LLC Doing Business AS Kalitec MedicalUnited States | Image Guided Surgery | Class 2 | 2023-12-13 |
| K231527 | TriALTIS Navigation Enabled InstrumentsSpine Surgery | Medos International SARLSwitzerland | Image Guided Surgery | Class 2 | 2023-09-29 |
| K232116 | CoreLink Navigation InstrumentsSpine Surgery | Corelink, LLCUnited States | Image Guided Surgery | Class 2 | 2023-08-16 |
| K231886 | SURGIVISIO DeviceSpine Surgery | Ecential RoboticsFrance | Image Guided Surgery | Class 2 | 2023-07-27 |
| K223301 | ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpine Surgery | Spinecraft, LLCUnited States | Image Guided Surgery | Class 2 | 2023-07-20 |
| K223558 | CUVIS-spineSpine Surgery | Curexo, Inc.Korea, Republic of | Image Guided Surgery | Class 2 | 2023-06-22 |
| K231229 | S-COMP Reform® POCT Navigation InstrumentsSpine Surgery | Precision Spine, Inc.United States | Image Guided Surgery | Class 2 | 2023-05-25 |
| K223511 | Excella Navigation InstrumentsSpine Surgery | Innovasis, Inc.United States | Image Guided Surgery | Class 2 | 2023-05-02 |
| K230783 | Anatase Spine Surgery Navigation SystemSpine Surgery | Remex Medical Corp.Taiwan | Image Guided Surgery | Class 2 | 2023-04-21 |
| K222291 | Paradigm SystemSpine Surgery | Proprio, Inc.United States | Image Guided Surgery | Class 2 | 2023-04-21 |
| K223765 | ATEC Lateral Navigation InstrumentsSpine Surgery | Alphatec Spine, Inc.United States | Image Guided Surgery | Class 2 | 2023-03-23 |
| K222355 | PathKeeper SystemSpine Surgery | Pathkeeper Surgical , Ltd.Israel | Image Guided Surgery | Class 2 | 2023-03-08 |
| K223200 | Curiteva Navigation SystemSpine Surgery | Curiteva, Inc.United States | Image Guided Surgery | Class 2 | 2023-01-06 |
| K221618 | Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm SystemSpine Surgery | Brainlab AGGermany | Image Guided Surgery | Class 2 | 2022-08-30 |
| K213876 | Spineology Navigation InstrumentsSpine Surgery | Spineology, Inc.United States | Image Guided Surgery | Class 2 | 2022-08-05 |
| K221028 | SURGIVISIO DeviceSpine Surgery | Ecential RoboticsFrance | Image Guided Surgery | Class 2 | 2022-07-06 |
| K220024 | ChoiceSpine Navigation SystemSpine Surgery | Choice Spine, LLCUnited States | Image Guided Surgery | Class 2 | 2022-07-06 |
| K221180 | Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsSpine Surgery | Medtronic Sofamor Danek USA, Inc.United States | Image Guided Surgery | Class 2 | 2022-05-25 |
| K220522 | 7D Surgical System - Percutaneous Application (7D Flash Frame)Spine Surgery | 7D SurgicalCanada | Image Guided Surgery | Class 2 | 2022-05-20 |
| 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 PlanningSpine Surgery | Brainlab AGGermany | Image Guided Surgery | Class 2 | 2022-04-13 |
| K220291 | NEXXT SPINE NAVIGATION SystemSpine Surgery | Nexxt Spine, LLCUnited States | Image Guided Surgery | Class 2 | 2022-03-31 |
| K213380 | 360CASKnee Surgery | Kico Knee Innovation Company Pty, Ltd.Australia | Image Guided Surgery | Class 2 | 2022-01-11 |