510(k) submissions
Filtered by Robotic Assistance · showing 1–14 of 14
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K252037 | CUVIS-joint (CJ150)Knee Surgery | Curexo, Inc.Korea, Republic of | Robotic Navigation | Class 2 | 2026-03-25 |
| 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 |
| 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 |
| K240568 | DuraPro™ Oscillating SystemSpine Surgery | Globus Medical, Inc.United States | Robotic Navigation | Class 2 | 2024-04-29 |
| K233199 | ROSA® Shoulder SystemOther | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2024-02-21 |
| K233227 | VELYS™ Robotic-Assisted SolutionKnee Surgery | Depuy Ireland UCIreland | Stereotactic Surgery | Class 2 | 2023-12-14 |
| K232533 | ROSA Partial Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2023-11-16 |
| 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 |
| K230180 | Rosa Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2023-02-22 |
| 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 |