FDA Product Code
FDA Product Code OLO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4560
510(k) Clearances — 441 records · page 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241082 | INNOVERSE Navigation Instruments | Innosys Co., Ltd. | 2024-06-14 | Traditional | PDF ↗ |
| K233254 | TELIGEN System Navigation Ready Instruments | DePuy Synthes | 2024-06-14 | Traditional | PDF ↗ |
| K233228 | Spine Navigation and Robotic-Assistance Device | Ecential Robotics | 2024-06-14 | Traditional | PDF ↗ |
| K241011 | Mako Total Knee Application | Mako Surgical Corp. | 2024-06-11 | Traditional | PDF ↗ |
| K240951 | Invictus Robotic Navigation Instruments | Alphatec Spine | 2024-06-06 | Traditional | PDF ↗ |
| 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 Handpiece | Stryker Leibinger GmbH & Co KG | 2024-06-06 | Traditional | PDF ↗ |
| K240211 | VELYS Robotic-Assisted Solution | Depuy Ireland UC | 2024-06-05 | Traditional | PDF ↗ |
| K240701 | Drill Guide; Drill Bit; Spine & Trauma Navigation | Brainlab AG | 2024-05-23 | Special | PDF ↗ |
| K240625 | CORUS Navigation Access System | Providence Medical Technology, Inc. | 2024-05-03 | Traditional | PDF ↗ |
| K233513 | Remex Spine Surgery Navigation System II | Remex Medical Corp. | 2024-05-01 | Special | PDF ↗ |
| K240062 | ARVIS® Shoulder | Insight Medical Systems, Inc. | 2024-04-29 | Traditional | PDF ↗ |
| K240568 | DuraPro Oscillating System | Globus Medical, Inc. | 2024-04-29 | Traditional | PDF ↗ |
| K240647 | Virage® Navigation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2024-04-05 | Special | PDF ↗ |
| K233595 | Genesys Spine Sacroiliac Joint Fusion System with Navigation | Genesys Spine | 2024-03-29 | Traditional | PDF ↗ |
| K234047 | Automatic Registration | Brainlab AG | 2024-03-20 | Traditional | PDF ↗ |
| K240139 | Real Intelligence CORI | Blue Belt Technologies, Inc. | 2024-03-18 | Traditional | PDF ↗ |
| K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System | Stryker Leibinger GmbH & Co KG | 2024-03-14 | Traditional | PDF ↗ |
| K232140 | OTS Hip | Ortoma AB | 2024-03-11 | Traditional | PDF ↗ |
| K230195 | Neo ADVISE software | Comerge AG | 2024-03-08 | Traditional | PDF ↗ |
| K232800 | Navigation Tracking Instruments | SI-BONE, Inc. | 2024-02-23 | Traditional | PDF ↗ |
| K233199 | ROSA® Shoulder System | Orthosoft Inc (D/B/A Zimmer Cas) | 2024-02-21 | Traditional | PDF ↗ |
| K233638 | VERZA High Speed Drills | Globus Medical, Inc. | 2024-02-09 | Traditional | PDF ↗ |
| K233299 | ExactechGPS® System | Blue Ortho | 2024-01-26 | Traditional | PDF ↗ |
| K233227 | VELYS Robotic-Assisted Solution | Depuy Ireland UC | 2023-12-14 | Special | PDF ↗ |
| K232572 | Kalitec Navigated Instrument System | Kalitec Direct, LLC Doing Business AS Kalitec Medical | 2023-12-13 | Traditional | PDF ↗ |
| K230700 | RIWOtrack Navigation System | Fiagon GmbH | 2023-11-20 | Traditional | PDF ↗ |
| K233443 | Vital Navigation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2023-11-16 | Special | PDF ↗ |
| K232521 | ExactechGPS® Total Ankle Application | Blue Ortho | 2023-11-16 | Traditional | PDF ↗ |
| K232533 | ROSA Partial Knee System | Orthosoft D/B/A Zimmer Cas | 2023-11-16 | Traditional | PDF ↗ |
| K232345 | ATEC Posterior Navigated Disc Prep Instruments | Alphatec Spine, Inc. | 2023-11-02 | Traditional | PDF ↗ |
| K231494 | CoreLink Robotic Navigation Instruments | Corelink, LLC | 2023-10-27 | Traditional | PDF ↗ |
| K232802 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2023-10-12 | Special | PDF ↗ |
| K232044 | Invictus Robotic Navigation Instruments | Alphatec Spine, Inc. | 2023-10-06 | Traditional | PDF ↗ |
| K231527 | TriALTIS Navigation Enabled Instruments | Medos International Sàrl | 2023-09-29 | Traditional | PDF ↗ |
| K232413 | Fusion Robotic Navigation System | Alphatec Spine, Inc. | 2023-09-08 | Special | PDF ↗ |
| K232116 | CoreLink Navigation Instruments | Corelink, LLC | 2023-08-16 | Special | PDF ↗ |
| K223553 | Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine | Brainlab AG | 2023-08-02 | Traditional | PDF ↗ |
| K231963 | REAL INTELLIGENCE CORI | Blue Belt Technologies, Inc. | 2023-08-01 | Special | PDF ↗ |
| K231886 | SURGIVISIO Device | Ecential Robotics | 2023-07-27 | Special | PDF ↗ |
| K231172 | ApolloKnee | Corin U.S.A. Limited | 2023-07-26 | Traditional | PDF ↗ |
| K223301 | ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System | Spinecraft, LLC | 2023-07-20 | Traditional | PDF ↗ |
| K230716 | Robotic Graft Delivery Instruments | Medtronic Sofamor Danek, Inc. | 2023-07-18 | Traditional | PDF ↗ |
| K230087 | POINT Kinguide Agile Hybrid Navigation System | Point Robotics MedTech, Inc. | 2023-07-17 | Traditional | PDF ↗ |
| K223808 | Zavation Navigation Instrument System | Zavation Medical Products, LLC | 2023-07-12 | Traditional | PDF ↗ |
| K230861 | VADER® Pedicle System Navigated Instruments | Icotec AG | 2023-06-27 | Traditional | PDF ↗ |
| K230876 | RI.KNEE Adjustable Tibia Cut Guide | Enztec Limited | 2023-06-27 | Traditional | PDF ↗ |
| K230369 | EUROPA Navigated Instruments | MiRus, LLC | 2023-06-23 | Traditional | PDF ↗ |
| K223558 | CUVIS-spine | Curexo, Inc. | 2023-06-22 | Traditional | PDF ↗ |
| K231184 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2023-05-26 | Special | PDF ↗ |
| K231229 | S-COMP Reform® POCT Navigation Instruments | Precision Spine, Inc. | 2023-05-25 | Special | PDF ↗ |
| K230989 | Rod Registration Frame | Nu Vasive, Incorporated | 2023-05-05 | Special | PDF ↗ |
| K223511 | Excella Navigation Instruments | Innovasis, Inc. | 2023-05-02 | Traditional | PDF ↗ |
| K230880 | CoreLink Navigation Instruments | Corelink, LLC | 2023-05-02 | Special | PDF ↗ |
| K230202 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2023-04-25 | Traditional | PDF ↗ |
| K230783 | Anatase Spine Surgery Navigation System | Remex Medical Corp. | 2023-04-21 | Special | PDF ↗ |
| K222291 | Paradigm System | Proprio, Inc. | 2023-04-21 | Traditional | PDF ↗ |
| K230064 | Mazor X System (Mazor X Stealth Edition) | Mazor Robotics , Ltd. | 2023-04-07 | Traditional | PDF ↗ |
| K230243 | ROSA® Knee System | Orthosoft D/B/A Zimmer Cas | 2023-03-29 | Traditional | PDF ↗ |
| K223765 | ATEC Lateral Navigation Instruments | Alphatec Spine, Inc. | 2023-03-23 | Traditional | PDF ↗ |
| K223350 | Remi Robotic Navigation System | Fusion Robotics, LLC | 2023-03-13 | Traditional | PDF ↗ |
| K222355 | PathKeeper System | Pathkeeper Surgical , Ltd. | 2023-03-08 | Traditional | PDF ↗ |
| K230180 | Rosa Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2023-02-22 | Special | PDF ↗ |
| K223767 | Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System | Stryker Leibinger GmbH & Co KG | 2023-02-13 | Traditional | PDF ↗ |
| K223351 | Naviswiss Knee | Naviswiss AG | 2023-01-31 | Traditional | PDF ↗ |
| K223927 | 360CAS | Kico Knee Innovation Company Pty Limited | 2023-01-27 | Special | PDF ↗ |
| K222510 | Blueprint Mixed Reality system | Tornier S.A.S. | 2023-01-20 | Traditional | PDF ↗ |
| K223108 | TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) | Medos International SARL | 2023-01-19 | Traditional | PDF ↗ |
| K223200 | Curiteva Navigation System | Curiteva, Inc. | 2023-01-06 | Traditional | PDF ↗ |
| K223649 | VERTICALE® Navigation Instruments | Silony Medical GmbH | 2022-12-22 | Special | PDF ↗ |
| K222753 | SeaSpine 7D Navigation Instruments | SeaSpine Orthopedics Corporation | 2022-12-09 | Traditional | PDF ↗ |
| K220774 | RobPath® Total Hip Application | Hangzhou Lancet Robotics Co., Ltd. | 2022-12-09 | Traditional | PDF ↗ |
| K223070 | Remi Robotic Navigation System | Fusion Robotics, LLC | 2022-10-28 | Special | PDF ↗ |
| K222966 | Cirq Arm System (2.0);Alignment System Spine | Brainlab AG | 2022-10-27 | Special | PDF ↗ |
| K222698 | CUVIS-spine | Curexo, Inc. | 2022-10-07 | Special | PDF ↗ |
| K221928 | ROSA® Knee System | Orthosoft D/B/A Zimmer Cas | 2022-10-04 | Traditional | PDF ↗ |
| K222383 | Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition | Medtronic Sofamor Danek USA, Inc. | 2022-09-29 | Special | PDF ↗ |
| K221618 | Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System | Brainlab AG | 2022-08-30 | Traditional | PDF ↗ |
| K221224 | REAL INTELLIGENCE CORI | Blue Belt Technologies, Inc. | 2022-08-19 | Traditional | PDF ↗ |
| K220241 | POINT Kinguide Robotic-Assisted Surgical System | Point Robotics MedTech, Inc. | 2022-08-09 | Traditional | PDF ↗ |
| K213876 | Spineology Navigation Instruments | Spineology, Inc. | 2022-08-05 | Traditional | PDF ↗ |
| K220958 | Real Intelligence Cori | Blue Belt Technologies, Inc. | 2022-07-27 | Traditional | PDF ↗ |
| K220862 | E-GPS Navigated Instruments | Precision Spine, Inc. | 2022-07-14 | Traditional | PDF ↗ |
| K220348 | Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V | Remex Medical Corporation | 2022-07-14 | Traditional | PDF ↗ |
| K213873 | SkyWalker Total Knee System | Microport Navibot International, LLC | 2022-07-07 | Traditional | PDF ↗ |
| K221028 | SURGIVISIO Device | Ecential Robotics | 2022-07-06 | Traditional | PDF ↗ |
| K220024 | ChoiceSpine Navigation System | Choice Spine, LLC | 2022-07-06 | Traditional | PDF ↗ |
| K220652 | Knee 3 | Brainlab AG | 2022-06-03 | Traditional | PDF ↗ |
| K220973 | CoreLink Navigation Instruments | Corelink, LLC | 2022-06-01 | Traditional | PDF ↗ |
| K220146 | VisAR | Novarad Corporation | 2022-05-27 | Traditional | PDF ↗ |
| K220593 | Spine Guidance Software, Stryker Q Guidance System | Stryker Leibinger GmbH & Co KG | 2022-05-27 | Traditional | PDF ↗ |
| K221180 | Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments | Medtronic Sofamor Danek USA, Inc. | 2022-05-25 | Special | PDF ↗ |
| K220522 | 7D Surgical System - Percutaneous Application (7D Flash Frame) | 7D Surgical | 2022-05-20 | Special | PDF ↗ |
| K213491 | Universal Pilot Guidance Instrument System | Ctl Medical Corporation | 2022-05-12 | Traditional | PDF ↗ |
| K212756 | Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set | Medos International SARL | 2022-05-05 | Traditional | PDF ↗ |
| K213877 | ExactechGPS® System | Blue Ortho | 2022-05-02 | Traditional | PDF ↗ |
| K220038 | Camber Spine Navigation System | Camber Spine Technologies | 2022-04-29 | Traditional | PDF ↗ |
| K213708 | ROSA® Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2022-04-22 | Traditional | PDF ↗ |
| K220459 | Mako Total Knee Application | Mako Surgical Corp. | 2022-04-15 | Traditional | PDF ↗ |
| 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 Planning | Brainlab AG | 2022-04-13 | Traditional | PDF ↗ |
| K220291 | NEXXT SPINE NAVIGATION System | Nexxt Spine, LLC | 2022-03-31 | Traditional | PDF ↗ |
Product code OLO · Class II · Neurology. Data: openFDA.