510(k) submissions
All indexed OLO clearances · showing 151–196 of 196
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| 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 |
| K223927 | 360CASKnee Surgery | Kico Knee Innovation Company Pty, Ltd.Australia | Software Navigation | Class 2 | 2023-01-27 |
| K222510 | Blueprint Mixed Reality system | Tornier S.A.S.France | — | Class 2 | 2023-01-20 |
| 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 |
| K220774 | RobPath® Total Hip Application | Hangzhou Lancet Robotics Co., Ltd.China | — | 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 |
| K220241 | “POINT” Kinguide Robotic-Assisted Surgical System | Point Robotics MedTech, Inc.Taiwan | — | Class 2 | 2022-08-09 |
| K213876 | Spineology Navigation InstrumentsSpine Surgery | Spineology, Inc.United States | Image Guided Surgery | Class 2 | 2022-08-05 |
| K220958 | Real Intelligence CoriKnee Surgery | Blue Belt Technologies, Inc.United States | Software Navigation | Class 2 | 2022-07-27 |
| K220862 | E-GPS Navigated InstrumentsSpine Surgery | Precision Spine, Inc.United States | Robotic Navigation | Class 2 | 2022-07-14 |
| K220348 | Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V | Remex Medical Corp.Taiwan | — | 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 |
| K220146 | VisAR | Novarad CorporationUnited States | — | 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 |
| K220038 | Camber Spine Navigation System | Camber Spine TechnologiesUnited States | — | Class 2 | 2022-04-29 |
| K213708 | ROSA® Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2022-04-22 |
| K220459 | Mako Total Knee Application | Mako Surgical Corp.United States | — | Class 2 | 2022-04-15 |
| 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 |
| K220255 | REAL INTELLIGENCE CORI | Blue Belt Technologies, Inc.United States | — | Class 2 | 2022-03-29 |
| 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 |
| K213033 | iASSIST Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2022-01-14 |
| K213380 | 360CASKnee Surgery | Kico Knee Innovation Company Pty, Ltd.Australia | Image Guided Surgery | Class 2 | 2022-01-11 |
| K213720 | Vital Navigation SystemSpine Surgery | Zimvie (Zimmer Biomet Spine, Inc.)United States | Image Guided Surgery | Class 2 | 2022-01-07 |
| K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareNavigation System | Blue OrthoFrance | Software Navigation | Class 2 | 2022-01-06 |