510(k) submissions
Filtered by Navigation System · showing 101–150 of 156
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| K223767 | Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance SystemKnee Surgery | Stryker Leibinger GmbH & Co KGGermany | Software Navigation | Class 2 | 2023-02-13 |
| K223351 | Naviswiss KneeKnee Surgery | Naviswiss AGSwitzerland | Software Navigation | Class 2 | 2023-01-31 |
| 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 |
| K221928 | ROSA® Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2022-10-04 |
| 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 |
| K221224 | REAL INTELLIGENCE CORIKnee Surgery | Blue Belt Technologies, Inc.United States | Software Navigation | Class 2 | 2022-08-19 |
| 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 |
| K213873 | SkyWalker Total Knee SystemKnee Surgery | Microport Navibot International, LLCUnited States | Stereotactic Surgery | Class 2 | 2022-07-07 |
| 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 |
| K220652 | Knee 3Knee Surgery | Brainlab AGGermany | Stereotactic Surgery | Class 2 | 2022-06-03 |
| 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 |
| K213877 | ExactechGPS® SystemKnee Surgery | Blue OrthoFrance | Stereotactic Surgery | Class 2 | 2022-05-02 |
| 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 |