510(k) submissions
Filtered by Spine Surgery · showing 51–100 of 127
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K240160 | EGPS Navigated InstrumentsSpine Surgery | Astura MedicalUnited States | Robotic Navigation | Class 2 | 2024-10-17 |
| 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 |
| K241644 | SPINEART Navigation Instrument SystemSpine Surgery | Spineart SASwitzerland | Image Guided Surgery | Class 2 | 2024-08-07 |
| K233725 | Spine Navigation SystemSpine Surgery | Medivis, Inc.United States | Stereotactic Surgery | Class 2 | 2024-07-26 |
| 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 |
| K241625 | Anatase Navi Disposable InstrumentSpine Surgery | Remex Medical Corp.Taiwan | Image Guided Surgery | Class 2 | 2024-07-05 |
| K233256 | Robotic Integration InstrumentsSpine Surgery | DePuy SynthesSwitzerland | Robotic Navigation | Class 2 | 2024-06-17 |
| K233255 | CROSSNAV Navigation Enabled InstrumentsSpine Surgery | DePuy SynthesSwitzerland | Image Guided Surgery | Class 2 | 2024-06-17 |
| K241082 | INNOVERSE Navigation InstrumentsSpine Surgery | Innosys Co., Ltd.Korea, Republic of | Stereotactic Surgery | Class 2 | 2024-06-14 |
| K233254 | TELIGEN System Navigation Ready InstrumentsSpine Surgery | DePuy SynthesSwitzerland | Stereotactic Surgery | Class 2 | 2024-06-14 |
| 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 |
| 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 |
| K240701 | Drill Guide; Drill Bit; Spine & Trauma NavigationSpine Surgery | Brainlab AGUnited States | Image Guided Surgery | Class 2 | 2024-05-23 |
| K240625 | CORUS Navigation Access SystemSpine Surgery | Providence Medical Technology, Inc.United States | Image Guided Surgery | Class 2 | 2024-05-03 |
| K233513 | Remex Spine Surgery Navigation System IISpine Surgery | Remex Medical Corp.Taiwan | Image Guided Surgery | Class 2 | 2024-05-01 |
| K240568 | DuraPro™ Oscillating SystemSpine Surgery | Globus Medical, Inc.United States | Robotic Navigation | Class 2 | 2024-04-29 |
| 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 |
| 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 |
| K233638 | VERZA™ High Speed DrillsSpine Surgery | Globus Medical, Inc.United States | Other | Class 2 | 2024-02-09 |
| 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 |
| 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 |
| 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 |
| K231886 | SURGIVISIO DeviceSpine Surgery | Ecential RoboticsFrance | Image Guided Surgery | Class 2 | 2023-07-27 |
| 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 |
| 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 |
| 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 |
| K223765 | ATEC Lateral Navigation InstrumentsSpine Surgery | Alphatec Spine, Inc.United States | Image Guided Surgery | Class 2 | 2023-03-23 |
