510(k) submissions
Filtered by Other · showing 1–37 of 37
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| 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 |
| K252989 | “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetSpine Surgery | Point Robotics MedTech, Inc.Taiwan | Image Guided Surgery | Class 2 | 2026-02-20 |
| 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 |
| 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 |
| K252962 | DYNAMIS™ Navigation SystemSpine Surgery | Promethean Restorative, LLCUnited States | Image Guided Surgery | Class 2 | 2026-01-12 |
| K252841 | REAL INTELLIGENCE™ CORI™ XT (CORI XT)Knee Surgery | Blue Belt Technologies, Inc.United States | Stereotactic Surgery | Class 2 | 2025-12-05 |
| K250599 | ExcelsiusGPS™ InstrumentsSpine Surgery | Globus Medical, Inc.United States | Software Navigation | Class 2 | 2025-11-05 |
| 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 |
| K250086 | OTS HipNavigation System | Ortoma ABSweden | Image Guided Surgery | Class 2 | 2025-05-16 |
| K243958 | Consolidated Operating Room Equipment (CORE) 2 ConsoleSpine Surgery | Stryker InstrumentsUnited States | Stereotactic Surgery | Class 2 | 2025-03-21 |
| K243751 | Mako Total Hip Application 5.0Other | Mako Surgical Corp.United States | Stereotactic Surgery | Class 2 | 2025-03-05 |
| 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 |
| K242373 | Mako Shoulder Application (1.0)Other | Mako Surgical Corp.United States | Stereotactic Surgery | Class 2 | 2024-11-07 |
| 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 |
| K241130 | “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Spine Surgery | Point Robotics MedTech, Inc.Taiwan | Software Navigation | Class 2 | 2024-07-24 |
| K240721 | ExcelsiusFlex™Knee Surgery | Globus Medical, Inc.United States | Software Navigation | Class 2 | 2024-06-14 |
| K240701 | Drill Guide; Drill Bit; Spine & Trauma NavigationSpine Surgery | Brainlab AGUnited States | Image Guided Surgery | Class 2 | 2024-05-23 |
| K240139 | Real Intelligence™ CORI™Knee Surgery | Blue Belt Technologies, Inc.United States | Software Navigation | Class 2 | 2024-03-18 |
| K232140 | OTS HipNavigation System | Ortoma ABSweden | Image Guided Surgery | Class 2 | 2024-03-11 |
| K233199 | ROSA® Shoulder SystemOther | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2024-02-21 |
| K233638 | VERZA™ High Speed DrillsSpine Surgery | Globus Medical, Inc.United States | Other | Class 2 | 2024-02-09 |
| K232521 | ExactechGPS® Total Ankle ApplicationNavigation System | Blue OrthoFrance | Software Navigation | Class 2 | 2023-11-16 |
| K231963 | REAL INTELLIGENCE™ CORI™Knee Surgery | Blue Belt Technologies, Inc.United States | Software Navigation | Class 2 | 2023-08-01 |
| K231886 | SURGIVISIO DeviceSpine Surgery | Ecential RoboticsFrance | Image Guided Surgery | Class 2 | 2023-07-27 |
| K230087 | “POINT” Kinguide Agile Hybrid Navigation SystemSpine Surgery | Point Robotics MedTech, Inc.Taiwan | Software Navigation | Class 2 | 2023-07-17 |
| K223927 | 360CASKnee Surgery | Kico Knee Innovation Company Pty, Ltd.Australia | Software Navigation | Class 2 | 2023-01-27 |
| K221224 | REAL INTELLIGENCE CORIKnee Surgery | Blue Belt Technologies, Inc.United States | Software Navigation | Class 2 | 2022-08-19 |
| K220958 | Real Intelligence CoriKnee Surgery | Blue Belt Technologies, Inc.United States | Software Navigation | Class 2 | 2022-07-27 |
| K221028 | SURGIVISIO DeviceSpine Surgery | Ecential RoboticsFrance | Image Guided Surgery | Class 2 | 2022-07-06 |
| 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 |
| K213380 | 360CASKnee Surgery | Kico Knee Innovation Company Pty, Ltd.Australia | Image Guided Surgery | Class 2 | 2022-01-11 |
| K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareNavigation System | Blue OrthoFrance | Software Navigation | Class 2 | 2022-01-06 |