510(k) submissions
Filtered by Spine Surgery · showing 1–50 of 127
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsSpine Surgery | Life Spine, Inc.United States | Robotic Navigation | Class 2 | 2026-06-02 |
| K261060 | Navigated LLIF Impactable TrackerSpine Surgery | Tyber Medical, LLCUnited States | Stereotactic Surgery | Class 2 | 2026-05-29 |
| K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodySpine Surgery | Medos International SARLSwitzerland | Software Navigation | Class 2 | 2026-05-26 |
| K260329 | Ion-C Navigation InstrumentsSpine Surgery | SurGenTec, LLCUnited States | Image Guided Surgery | Class 2 | 2026-05-22 |
| K252880 | Pytheas Your Guided TrajectorySpine Surgery | Pytheas Navigation SasFrance | Software Navigation | Class 2 | 2026-05-11 |
| K260011 | Foundation Surgical Navigated Lateral Disc Prep InstrumentsSpine Surgery | Foundation Surgical Group, Inc.United States | Stereotactic Surgery | Class 2 | 2026-04-16 |
| K254158 | SPINEART Navigation Instrument SystemSpine Surgery | Spineart SASwitzerland | Stereotactic Surgery | Class 2 | 2026-04-09 |
| K260240 | SYMPHONY Navigation Ready InstrumentsSpine Surgery | Medos International SARLSwitzerland | Image Guided Surgery | Class 2 | 2026-03-27 |
| K253604 | TiLink-L Navigation InstrumentsNavigation System | SurGenTec, LLCUnited States | Stereotactic Surgery | Class 2 | 2026-03-20 |
| K253444 | EUROPA™ Posterior Cervical Fusion Navigated InstrumentsSpine Surgery | MiRus, LLCUnited States | Stereotactic Surgery | Class 2 | 2026-03-18 |
| K260546 | Q Pedicle InstrumentsSpine Surgery | K2m, Inc.United States | Software Navigation | Class 2 | 2026-03-17 |
| K252989 | “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetSpine Surgery | Point Robotics MedTech, Inc.Taiwan | Image Guided Surgery | Class 2 | 2026-02-20 |
| K254148 | VERTICALE GPS InstrumentsSpine Surgery | Silony Medical GmbHGermany | Robotic Navigation | Class 2 | 2026-02-19 |
| 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 MotorSpine Surgery | Stryker Leibinger GmbH & Co KGGermany | Stereotactic Surgery | Class 2 | 2026-02-19 |
| K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)Spine Surgery | Alphatec Spine, Inc.United States | Robotic Navigation | Class 2 | 2026-02-19 |
| 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 |
| K252873 | Q Interbody InstrumentsSpine Surgery | K2m, Inc.United States | Software Navigation | Class 2 | 2026-02-06 |
| K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting AccessoriesSpine Surgery | Stryker Leibinger GmbH & Co KGGermany | Software Navigation | Class 2 | 2026-02-06 |
| K252087 | Navigation Module of the Cortium® SystemSpine Surgery | Ulrich Medical USA, Inc.United States | Image Guided Surgery | Class 2 | 2026-02-03 |
| K252755 | POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemSpine Surgery | Point Robotics MedTech, Inc.Taiwan | Robotic Navigation | Class 2 | 2026-01-23 |
| 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 |
| K251943 | Spineology Navigation InstrumentsSpine Surgery | Spineology, Inc.United States | Software Navigation | Class 2 | 2025-12-04 |
| K250599 | ExcelsiusGPS™ InstrumentsSpine Surgery | Globus Medical, Inc.United States | Software Navigation | Class 2 | 2025-11-05 |
| K252088 | Firebird SI Navigation SystemSpine Surgery | Orthofix US, LLCUnited States | Software Navigation | Class 2 | 2025-10-31 |
| K252742 | Navigated InstrumentsSpine Surgery | Tyber Medical, LLCUnited States | Stereotactic Surgery | Class 2 | 2025-10-28 |
| K250520 | OsteoCentric Navigated Instruments SystemSpine Surgery | Osteocentric Technologies, Inc.United States | Image Guided Surgery | Class 2 | 2025-10-27 |
| K251282 | StealthStation S8 Spine SoftwareSpine Surgery | Medtronic Navigation, Inc.United States | Software Navigation | Class 2 | 2025-10-17 |
| K251780 | iGPS Navigation InstrumentsNavigation System | SI-BONE, Inc.United States | Stereotactic Surgery | Class 2 | 2025-09-15 |
| K252562 | Spine & Trauma Navigation InstrumentsSpine Surgery | Brainlab AGUnited States | Image Guided Surgery | Class 2 | 2025-09-12 |
| K251316 | Mazor X System / Mazor X Stealth EditionSpine Surgery | Mazor Robotics , Ltd.Israel | Software Navigation | Class 2 | 2025-09-11 |
| K250167 | Evolution Spine Navigation InstrumentsSpine Surgery | Evolution SpineUnited States | Software Navigation | Class 2 | 2025-08-18 |
| K251060 | CORUS™ Navigation System-GXSpine Surgery | Providence Medical Technology, Inc.United States | Software Navigation | Class 2 | 2025-07-30 |
| 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 |
| K242464 | Stealth™ Spine Clamps; ModuLeX™ Shank MountsSpine Surgery | Medtronic Navigation, Inc.United States | Stereotactic Surgery | Class 2 | 2025-06-05 |
| 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 |
| K243419 | Altus Spine Navigation SystemSpine Surgery | Altus Partners, LLCUnited States | Image Guided Surgery | Class 2 | 2025-05-08 |
| K243326 | Dynamis Robotic Surgical SystemSpine Surgery | LEM Surgical AGSwitzerland | Robotic Navigation | Class 2 | 2025-04-23 |
| K242806 | Medyssey Navigation SystemSpine Surgery | Medyssey Co, Ltd.Korea, Republic of | Image Guided Surgery | Class 2 | 2025-04-16 |
| K243514 | Salvo® Robotic Navigation InstrumentsSpine Surgery | Spine Wave, Inc.United States | Robotic Navigation | Class 2 | 2025-04-03 |
| K250182 | Innovasis Navigation InstrumentsSpine Surgery | Innovasis, Inc.United States | Stereotactic Surgery | Class 2 | 2025-03-24 |
| K243958 | Consolidated Operating Room Equipment (CORE) 2 ConsoleSpine Surgery | Stryker InstrumentsUnited States | Stereotactic Surgery | Class 2 | 2025-03-21 |
| 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 |
| 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 |