510(k) submissions
All indexed OLO clearances · showing 101–150 of 196
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| 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 |
| K234047 | Automatic RegistrationNavigation System | Brainlab AGUnited States | Image Guided Surgery | Class 2 | 2024-03-20 |
| 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 |
| K232140 | OTS HipNavigation System | Ortoma ABSweden | Image Guided Surgery | Class 2 | 2024-03-11 |
| K230195 | Neo ADVISE softwareSpine Surgery | Comerge AGSwitzerland | Software Navigation | Class 2 | 2024-03-08 |
| K232800 | Navigation Tracking InstrumentsSpine Surgery | SI-BONE, Inc.United States | Stereotactic Surgery | Class 2 | 2024-02-23 |
| 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 |
| K233299 | ExactechGPS® SystemKnee Surgery | Blue OrthoFrance | Stereotactic Surgery | Class 2 | 2024-01-26 |
| K233227 | VELYS™ Robotic-Assisted SolutionKnee Surgery | Depuy Ireland UCIreland | Stereotactic Surgery | Class 2 | 2023-12-14 |
| K232572 | Kalitec Navigated Instrument SystemSpine Surgery | Kalitec Direct, LLC Doing Business AS Kalitec MedicalUnited States | Image Guided Surgery | Class 2 | 2023-12-13 |
| K230700 | RIWOtrack Navigation SystemSpine Surgery | Fiagon GmbHUnited States | Stereotactic Surgery | Class 2 | 2023-11-20 |
| K233443 | Vital™ Navigation SystemSpine Surgery | Zimvie Spine (Zimmer Biomet Spine, Inc.)United States | Software Navigation | Class 2 | 2023-11-16 |
| K232533 | ROSA Partial Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2023-11-16 |
| K232521 | ExactechGPS® Total Ankle ApplicationNavigation System | Blue OrthoFrance | Software Navigation | Class 2 | 2023-11-16 |
| K232345 | ATEC Posterior Navigated Disc Prep Instruments | Alphatec Spine, Inc.United States | — | Class 2 | 2023-11-02 |
| K231494 | CoreLink Robotic Navigation InstrumentsSpine Surgery | Corelink, LLCUnited States | Robotic Navigation | Class 2 | 2023-10-27 |
| K232802 | TMINI™ Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2023-10-12 |
| K232044 | Invictus Robotic Navigation InstrumentsSpine Surgery | Alphatec Spine, Inc.United States | Robotic Navigation | Class 2 | 2023-10-06 |
| K231527 | TriALTIS Navigation Enabled InstrumentsSpine Surgery | Medos International SARLSwitzerland | Image Guided Surgery | Class 2 | 2023-09-29 |
| K232413 | Fusion Robotic Navigation SystemSpine Surgery | Alphatec Spine, Inc.United States | Robotic Navigation | Class 2 | 2023-09-08 |
| K232116 | CoreLink Navigation InstrumentsSpine Surgery | Corelink, LLCUnited States | Image Guided Surgery | Class 2 | 2023-08-16 |
| K223553 | Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine | Brainlab AGUnited States | — | Class 2 | 2023-08-02 |
| 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 |
| K231172 | ApolloKneeKnee Surgery | Corin U.S.A. LimitedUnited States | Stereotactic Surgery | Class 2 | 2023-07-26 |
| K223301 | ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpine Surgery | Spinecraft, LLCUnited States | Image Guided Surgery | Class 2 | 2023-07-20 |
| K230716 | Robotic Graft Delivery InstrumentsSpine Surgery | Medtronic Sofamor Danek, Inc.United States | Stereotactic Surgery | Class 2 | 2023-07-18 |
| K230087 | “POINT” Kinguide Agile Hybrid Navigation SystemSpine Surgery | Point Robotics MedTech, Inc.Taiwan | Software Navigation | Class 2 | 2023-07-17 |
| K223808 | Zavation Navigation Instrument SystemSpine Surgery | Zavation Medical Products, LLCUnited States | Stereotactic Surgery | Class 2 | 2023-07-12 |
| K230876 | RI.KNEE Adjustable Tibia Cut GuideKnee Surgery | Enztec LimitedNew Zealand | Robotic Navigation | Class 2 | 2023-06-27 |
| K230861 | VADER® Pedicle System Navigated InstrumentsSpine Surgery | Icotec AGSwitzerland | Stereotactic Surgery | Class 2 | 2023-06-27 |
| K230369 | EUROPA™ Navigated InstrumentsSpine Surgery | MiRus, LLCUnited States | Stereotactic Surgery | Class 2 | 2023-06-23 |
| K223558 | CUVIS-spineSpine Surgery | Curexo, Inc.Korea, Republic of | Image Guided Surgery | Class 2 | 2023-06-22 |
| K231184 | CD Horizon™ Spinal SystemSpine Surgery | Medtronic Sofamor Danek USA, Inc.United States | Stereotactic Surgery | Class 2 | 2023-05-26 |
| K231229 | S-COMP Reform® POCT Navigation InstrumentsSpine Surgery | Precision Spine, Inc.United States | Image Guided Surgery | Class 2 | 2023-05-25 |
| K230989 | Rod Registration FrameSpine Surgery | Nu Vasive, IncorporatedUnited States | Stereotactic Surgery | Class 2 | 2023-05-05 |
| K230880 | CoreLink Navigation InstrumentsSpine Surgery | Corelink, LLCUnited States | Stereotactic Surgery | Class 2 | 2023-05-02 |
| K223511 | Excella Navigation InstrumentsSpine Surgery | Innovasis, Inc.United States | Image Guided Surgery | Class 2 | 2023-05-02 |
| K230202 | TMINI™ Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2023-04-25 |
| K230783 | Anatase Spine Surgery Navigation SystemSpine Surgery | Remex Medical Corp.Taiwan | Image Guided Surgery | Class 2 | 2023-04-21 |
| K222291 | Paradigm SystemSpine Surgery | Proprio, Inc.United States | Image Guided Surgery | Class 2 | 2023-04-21 |
| K230064 | Mazor X System (Mazor X Stealth Edition)Spine Surgery | Mazor Robotics , Ltd.Israel | Robotic Navigation | Class 2 | 2023-04-07 |
| K230243 | ROSA® Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2023-03-29 |
| K223765 | ATEC Lateral Navigation InstrumentsSpine Surgery | Alphatec Spine, Inc.United States | Image Guided Surgery | Class 2 | 2023-03-23 |
| K223350 | Remi Robotic Navigation SystemSpine Surgery | Fusion Robotics, LLCUnited States | Robotic Navigation | Class 2 | 2023-03-13 |
| K222355 | PathKeeper SystemSpine Surgery | Pathkeeper Surgical , Ltd.Israel | Image Guided Surgery | Class 2 | 2023-03-08 |
| K230180 | Rosa Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2023-02-22 |