510(k) submissions
Filtered by Robotic Navigation · showing 1–20 of 20
| 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 |
| K252037 | CUVIS-joint (CJ150)Knee Surgery | Curexo, Inc.Korea, Republic of | Robotic Navigation | Class 2 | 2026-03-25 |
| K254148 | VERTICALE GPS InstrumentsSpine Surgery | Silony Medical GmbHGermany | Robotic Navigation | 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 |
| K252755 | POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemSpine Surgery | Point Robotics MedTech, Inc.Taiwan | Robotic Navigation | Class 2 | 2026-01-23 |
| K243326 | Dynamis Robotic Surgical SystemSpine Surgery | LEM Surgical AGSwitzerland | Robotic Navigation | Class 2 | 2025-04-23 |
| K243514 | Salvo® Robotic Navigation InstrumentsSpine Surgery | Spine Wave, Inc.United States | Robotic Navigation | Class 2 | 2025-04-03 |
| K240160 | EGPS Navigated InstrumentsSpine Surgery | Astura MedicalUnited States | Robotic Navigation | Class 2 | 2024-10-17 |
| K233256 | Robotic Integration InstrumentsSpine Surgery | DePuy SynthesSwitzerland | Robotic Navigation | Class 2 | 2024-06-17 |
| K233228 | Spine Navigation and Robotic-Assistance DeviceSpine Surgery | Ecential RoboticsFrance | Robotic Navigation | Class 2 | 2024-06-14 |
| K240951 | Invictus Robotic Navigation InstrumentsSpine Surgery | Alphatec Spine, Inc.United States | Robotic Navigation | Class 2 | 2024-06-06 |
| K240568 | DuraPro™ Oscillating SystemSpine Surgery | Globus Medical, Inc.United States | Robotic Navigation | Class 2 | 2024-04-29 |
| K231494 | CoreLink Robotic Navigation InstrumentsSpine Surgery | Corelink, LLCUnited States | Robotic Navigation | Class 2 | 2023-10-27 |
| K232044 | Invictus Robotic Navigation InstrumentsSpine Surgery | Alphatec Spine, Inc.United States | Robotic Navigation | Class 2 | 2023-10-06 |
| K232413 | Fusion Robotic Navigation SystemSpine Surgery | Alphatec Spine, Inc.United States | Robotic Navigation | Class 2 | 2023-09-08 |
| K230876 | RI.KNEE Adjustable Tibia Cut GuideKnee Surgery | Enztec LimitedNew Zealand | Robotic Navigation | Class 2 | 2023-06-27 |
| K230064 | Mazor X System (Mazor X Stealth Edition)Spine Surgery | Mazor Robotics , Ltd.Israel | Robotic Navigation | Class 2 | 2023-04-07 |
| K223350 | Remi Robotic Navigation SystemSpine Surgery | Fusion Robotics, LLCUnited States | Robotic Navigation | Class 2 | 2023-03-13 |
| K223070 | Remi Robotic Navigation SystemSpine Surgery | Fusion Robotics, LLCUnited States | Robotic Navigation | Class 2 | 2022-10-28 |
| K220862 | E-GPS Navigated InstrumentsSpine Surgery | Precision Spine, Inc.United States | Robotic Navigation | Class 2 | 2022-07-14 |
