510(k) submissions
All indexed OLO clearances · showing 1–50 of 196
| 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 |
| K260582 | ROSA® Shoulder System | Orthosoft Inc. (d/b/a) Zimmer CASCanada | — | Class 2 | 2026-05-21 |
| 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 |
| K260601 | REAL INTELLIGENCE™ CORI™Knee Surgery | Blue Belt Technologies, Inc.United States | Stereotactic Surgery | Class 2 | 2026-03-26 |
| K252037 | CUVIS-joint (CJ150)Knee Surgery | Curexo, Inc.Korea, Republic of | Robotic Navigation | Class 2 | 2026-03-25 |
| 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 |
| K260010 | TMINI® Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2026-03-03 |
| K260222 | Mako Total Knee ApplicationKnee Surgery | Mako Surgical Corp.United States | Stereotactic Surgery | Class 2 | 2026-02-25 |
| 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 |
| K252058 | ROSA Knee System with UltraSound Imaging Platform (USIP)Knee Surgery | Balmoral Medical, LLCUnited States | Stereotactic Surgery | 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 |
| K253661 | TMINI Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2025-12-22 |
| K252950 | Paradigm SystemSpine Surgery | Proprio, Inc.United States | Image Guided Surgery | Class 2 | 2025-12-15 |
| K252841 | REAL INTELLIGENCE™ CORI™ XT (CORI XT)Knee Surgery | Blue Belt Technologies, Inc.United States | Stereotactic Surgery | Class 2 | 2025-12-05 |
| K251943 | Spineology Navigation InstrumentsSpine Surgery | Spineology, Inc.United States | Software Navigation | Class 2 | 2025-12-04 |
| K251314 | Rosa® Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2025-11-13 |
| 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 |
| K252544 | TMINI Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2025-10-10 |
| K251971 | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip PointerKnee Surgery | Stryker InstrumentsUnited States | Software Navigation | Class 2 | 2025-09-25 |
| 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 |
| K250877 | TMINI Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2025-06-20 |
| K242933 | SPINEART Navigation Instrument System | Spineart SASwitzerland | — | Class 2 | 2025-06-18 |
| 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 |
