510(k) submissions
Filtered by Software Navigation · showing 1–39 of 39
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodySpine Surgery | Medos International SARLSwitzerland | Software Navigation | Class 2 | 2026-05-26 |
| K252880 | Pytheas Your Guided TrajectorySpine Surgery | Pytheas Navigation SasFrance | Software Navigation | Class 2 | 2026-05-11 |
| K260546 | Q Pedicle InstrumentsSpine Surgery | K2m, Inc.United States | Software Navigation | Class 2 | 2026-03-17 |
| 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 |
| 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 |
| K251282 | StealthStation S8 Spine SoftwareSpine Surgery | Medtronic Navigation, Inc.United States | Software Navigation | Class 2 | 2025-10-17 |
| 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 |
| 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 |
| K242914 | Op.n(TM) NavigationSpine Surgery | Ecential RoboticsFrance | Software Navigation | Class 2 | 2025-03-07 |
| K243671 | ExcelsiusGPS® InstrumentsSpine Surgery | Globus Medical, Inc.United States | Software Navigation | Class 2 | 2024-12-20 |
| 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 |
| 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 |
| K240721 | ExcelsiusFlex™Knee Surgery | Globus Medical, Inc.United States | Software Navigation | Class 2 | 2024-06-14 |
| 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 |
| 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 |
| K240139 | Real Intelligence™ CORI™Knee Surgery | Blue Belt Technologies, Inc.United States | Software Navigation | Class 2 | 2024-03-18 |
| 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 |
| K230195 | Neo ADVISE softwareSpine Surgery | Comerge AGSwitzerland | Software Navigation | Class 2 | 2024-03-08 |
| 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 |
| K231963 | REAL INTELLIGENCE™ CORI™Knee Surgery | Blue Belt Technologies, Inc.United States | Software Navigation | Class 2 | 2023-08-01 |
| K230087 | “POINT” Kinguide Agile Hybrid Navigation SystemSpine Surgery | Point Robotics MedTech, Inc.Taiwan | Software Navigation | Class 2 | 2023-07-17 |
| K223767 | Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance SystemKnee Surgery | Stryker Leibinger GmbH & Co KGGermany | Software Navigation | Class 2 | 2023-02-13 |
| K223351 | Naviswiss KneeKnee Surgery | Naviswiss AGSwitzerland | Software Navigation | Class 2 | 2023-01-31 |
| K223927 | 360CASKnee Surgery | Kico Knee Innovation Company Pty, Ltd.Australia | Software Navigation | Class 2 | 2023-01-27 |
| K222966 | Cirq Arm System (2.0);Alignment System SpineSpine Surgery | Brainlab AGGermany | Software Navigation | Class 2 | 2022-10-27 |
| K222698 | CUVIS-spineSpine Surgery | Curexo, Inc.Korea, Republic of | Software Navigation | Class 2 | 2022-10-07 |
| 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 |
| K220593 | Spine Guidance Software, Stryker Q Guidance SystemSpine Surgery | Stryker Leibinger GmbH & Co KGGermany | Software Navigation | Class 2 | 2022-05-27 |
| K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareNavigation System | Blue OrthoFrance | Software Navigation | Class 2 | 2022-01-06 |