510(k) submissions
Filtered by Spine Surgery · showing 101–127 of 127
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| 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 |
| K223108 | TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)Spine Surgery | Medos International SARLSwitzerland | Stereotactic Surgery | Class 2 | 2023-01-19 |
| K223200 | Curiteva Navigation SystemSpine Surgery | Curiteva, Inc.United States | Image Guided Surgery | Class 2 | 2023-01-06 |
| K223649 | VERTICALE® Navigation InstrumentsSpine Surgery | Silony Medical GmbHGermany | Stereotactic Surgery | Class 2 | 2022-12-22 |
| K222753 | SeaSpine 7D Navigation InstrumentsSpine Surgery | SeaSpine Orthopedics CorporationUnited States | Stereotactic Surgery | Class 2 | 2022-12-09 |
| K223070 | Remi Robotic Navigation SystemSpine Surgery | Fusion Robotics, LLCUnited States | Robotic Navigation | Class 2 | 2022-10-28 |
| 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 |
| K222383 | Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) EditionSpine Surgery | Medtronic Sofamor Danek USA, Inc.United States | Stereotactic Surgery | Class 2 | 2022-09-29 |
| K221618 | Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm SystemSpine Surgery | Brainlab AGGermany | Image Guided Surgery | Class 2 | 2022-08-30 |
| K213876 | Spineology Navigation InstrumentsSpine Surgery | Spineology, Inc.United States | Image Guided Surgery | Class 2 | 2022-08-05 |
| K220862 | E-GPS Navigated InstrumentsSpine Surgery | Precision Spine, Inc.United States | Robotic Navigation | Class 2 | 2022-07-14 |
| K221028 | SURGIVISIO DeviceSpine Surgery | Ecential RoboticsFrance | Image Guided Surgery | Class 2 | 2022-07-06 |
| K220024 | ChoiceSpine Navigation SystemSpine Surgery | Choice Spine, LLCUnited States | Image Guided Surgery | Class 2 | 2022-07-06 |
| K220973 | CoreLink Navigation InstrumentsSpine Surgery | Corelink, LLCUnited States | Stereotactic Surgery | Class 2 | 2022-06-01 |
| K220593 | Spine Guidance Software, Stryker Q Guidance SystemSpine Surgery | Stryker Leibinger GmbH & Co KGGermany | Software Navigation | Class 2 | 2022-05-27 |
| K221180 | Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsSpine Surgery | Medtronic Sofamor Danek USA, Inc.United States | Image Guided Surgery | Class 2 | 2022-05-25 |
| K220522 | 7D Surgical System - Percutaneous Application (7D Flash Frame)Spine Surgery | 7D SurgicalCanada | Image Guided Surgery | Class 2 | 2022-05-20 |
| K213491 | Universal Pilot Guidance Instrument SystemSpine Surgery | Ctl Medical CorporationUnited States | Stereotactic Surgery | Class 2 | 2022-05-12 |
| K212756 | Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetSpine Surgery | Medos International SARLSwitzerland | Stereotactic Surgery | Class 2 | 2022-05-05 |
| 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 |
| K220291 | NEXXT SPINE NAVIGATION SystemSpine Surgery | Nexxt Spine, LLCUnited States | Image Guided Surgery | Class 2 | 2022-03-31 |
| K214011 | Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments, and CD Horizon™ Solera™ Voyager™ Spinal System Navigated, Guided, and Powered DriversSpine Surgery | Medtronic Sofamor Danek USA, Inc.United States | Stereotactic Surgery | Class 2 | 2022-02-09 |
| K213918 | DeGen Navigated InstrumentationSpine Surgery | Degen MedicalUnited States | Stereotactic Surgery | Class 2 | 2022-02-09 |
| K214059 | CoreLink Navigation InstrumentsSpine Surgery | Corelink, LLCUnited States | Stereotactic Surgery | Class 2 | 2022-01-19 |
| K213720 | Vital Navigation SystemSpine Surgery | Zimvie (Zimmer Biomet Spine, Inc.)United States | Image Guided Surgery | Class 2 | 2022-01-07 |