OLO
- 产品代码
- OLO
- 器械名称
- Orthopedic Stereotaxic Instrument
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 882.4560
- FDA 专业组
- Neurology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 440 件
FDA 分类定义
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
该代码近三年的 510(k)（133 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K262506 | 2026-08-20 | Remex Medical Corp. | Remex Spine Surgery Navigation - Universal Instrumen | FDA |
| K261410 | 2026-07-30 | Suite 201, National Innovation Centre | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), | |
| K261205 | 2026-07-29 | Spineart SA | SPINEART Navigation Instrument System | |
| K261024 | 2026-07-24 | THINK Surgical, Inc. | TMINI Miniature Robotic System | |
| K262121 | 2026-07-24 | SurGenTec, LLC | Ion-L Navigated Instruments | FDA |
| K261113 | 2026-07-22 | Ecential Robotics | Op.n Spine Navigation and Robotic Guidance | |
| K261852 | 2026-07-01 | Ortoma AB | OTS Hip | |
| K253921 | 2026-06-26 | Silony Medical GmbH | VERTICALE® Navigation Instruments | |
| K260480 | 2026-06-25 | Depuy Ireland UC | VELYS Robotic-Assisted Solution | |
| K260369 | 2026-06-20 | LEM Surgical AG | Dynamis Robotic Surgical System | |
| K261665 | 2026-06-18 | Providence Medical Technology, Inc. | CORUS Navigation System-GN | |
| K260571 | 2026-06-02 | Life Spine, Inc. | SIMPACT Sacroiliac Joint Fixation System GX Navigati | |
| K261060 | 2026-05-29 | Tyber Medical, LLC | Navigated LLIF Impactable Tracker | |
| K254157 | 2026-05-26 | Medos International SARL | CROSSNAV Navigation Enabled Instruments for Disc Pre | |
| K260329 | 2026-05-22 | SurGenTec, LLC | Ion-C Navigation Instruments | |
| K260582 | 2026-05-21 | Orthosoft Inc. (d/b/a) Zimmer CAS | ROSA® Shoulder System | |
| K252880 | 2026-05-11 | Pytheas Navigation Sas | Pytheas Your Guided Trajectory | |
| K260011 | 2026-04-16 | Foundation Surgical Group, Inc. | Foundation Surgical Navigated Lateral Disc Prep Inst | |
| K254158 | 2026-04-09 | Spineart SA | SPINEART Navigation Instrument System | |
| K260240 | 2026-03-27 | Medos International SARL | SYMPHONY Navigation Ready Instruments | |
| K260601 | 2026-03-26 | Blue Belt Technologies, Inc. | REAL INTELLIGENCE CORI | |
| K252037 | 2026-03-25 | Curexo, Inc. | CUVIS-joint (CJ150) | |
| K253604 | 2026-03-20 | SurGenTec, LLC | TiLink-L Navigation Instruments | |
| K253444 | 2026-03-18 | MiRus, LLC | EUROPA Posterior Cervical Fusion Navigated Instrume | |
| K260546 | 2026-03-17 | K2m, Inc. | Q Pedicle Instruments | |
| K260010 | 2026-03-03 | THINK Surgical, Inc. | TMINI® Miniature Robotic System | |
| K260222 | 2026-02-25 | Mako Surgical Corp. | Mako Total Knee Application | |
| K252989 | 2026-02-20 | Point Robotics MedTech, Inc. | POINT Kinguide Agile Hybrid Navigation System; DRF | |
| K253623 | 2026-02-19 | Stryker Leibinger GmbH & Co KG | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgr | |
| K254148 | 2026-02-19 | Silony Medical GmbH | VERTICALE GPS Instruments | |
| K252597 | 2026-02-19 | Alphatec Spine, Inc. | Valence Robotic Navigation System; Valence Robotic N | |
| K253381 | 2026-02-12 | Medtronic Navigation, Inc. | Stealth AXiS Surgical System with Stealth AXiS Spi | |
| K252058 | 2026-02-06 | Balmoral Medical, LLC | ROSA Knee System with UltraSound Imaging Platform (U | |
| K252871 | 2026-02-06 | Stryker Leibinger GmbH & Co KG | Spine Guidance 5.3 Software; Q Interbody Instruments | |
| K252873 | 2026-02-06 | K2m, Inc. | Q Interbody Instruments | |
| K252087 | 2026-02-03 | Ulrich Medical USA, Inc. | Navigation Module of the Cortium® System | |
| K252755 | 2026-01-23 | Point Robotics MedTech, Inc. | POINT Kinguide Agile Robotic Arm Surgical Stereotact | |
| K252962 | 2026-01-12 | Promethean Restorative, LLC | DYNAMIS Navigation System | |
| K253661 | 2025-12-22 | THINK Surgical, Inc. | TMINI Miniature Robotic System | |
| K252950 | 2025-12-15 | Proprio, Inc. | Paradigm System | |
| K252841 | 2025-12-05 | Blue Belt Technologies, Inc. | REAL INTELLIGENCE CORI XT (CORI XT) | |
| K251943 | 2025-12-04 | Spineology, Inc. | Spineology Navigation Instruments | |
| K251314 | 2025-11-13 | Orthosoft Inc. (d/b/a) Zimmer CAS | Rosa® Knee System | |
| K250599 | 2025-11-05 | Globus Medical, Inc. | ExcelsiusGPS Instruments | FDA |
| K252088 | 2025-10-31 | Orthofix US, LLC | Firebird SI Navigation System | |
| K252742 | 2025-10-28 | Tyber Medical, LLC | Navigated Instruments | |
| K250520 | 2025-10-27 | Osteocentric Technologies, Inc. | OsteoCentric Navigated Instruments System | |
| K251282 | 2025-10-17 | Medtronic Navigation, Inc. | StealthStation S8 Spine Software | |
| K252544 | 2025-10-10 | THINK Surgical, Inc. | TMINI Miniature Robotic System | |
| K251971 | 2025-09-25 | Stryker Instruments | RPS Primary TKA Software; RPS Console; RPS Saw One; | |
| K251780 | 2025-09-15 | SI-BONE, Inc. | iGPS Navigation Instruments | |
| K252562 | 2025-09-12 | Brainlab AG | Spine & Trauma Navigation Instruments | |
| K251316 | 2025-09-11 | Mazor Robotics , Ltd. | Mazor X System / Mazor X Stealth Edition | |
| K250167 | 2025-08-18 | Evolution Spine | Evolution Spine Navigation Instruments | |
| K251060 | 2025-07-30 | Providence Medical Technology, Inc. | CORUS Navigation System-GX | |
| K251073 | 2025-07-23 | Innovasis, Inc. | Innovasis Navigation Instruments (Vector G-E Navigat | |
| K250877 | 2025-06-20 | THINK Surgical, Inc. | TMINI Miniature Robotic System | |
| K242933 | 2025-06-18 | Spineart SA | SPINEART Navigation Instrument System | |
| K242464 | 2025-06-05 | Medtronic Navigation, Inc. | Stealth Spine Clamps; ModuLeX Shank Mounts | |
| K250879 | 2025-06-04 | Proprio, Inc. | Paradigm System | |
| K251315 | 2025-05-29 | Remex Medical Corp. | Anatase Spine Surgery Navigation System and Remex Sp | |
| K250086 | 2025-05-16 | Ortoma AB | OTS Hip | FDA |
| K243419 | 2025-05-08 | Altus Partners, LLC | Altus Spine Navigation System | |
| K250608 | 2025-04-25 | Mako Surgical Corp. | Mako Total Knee Application (3.0); Hybrid Tip Pointe | |
| K243326 | 2025-04-23 | LEM Surgical AG | Dynamis Robotic Surgical System | |
| K242806 | 2025-04-16 | Medyssey Co, Ltd. | Medyssey Navigation System | FDA |
| K243514 | 2025-04-03 | Spine Wave, Inc. | Salvo® Robotic Navigation Instruments | |
| K243659 | 2025-04-02 | SeaSpine Orthopedics Corporation | FLASH Facet Fusion Instruments, IsoTis® Facet Fusio | FDA |
| K250182 | 2025-03-24 | Innovasis, Inc. | Innovasis Navigation Instruments | |
| K243958 | 2025-03-21 | Stryker Instruments | Consolidated Operating Room Equipment (CORE) 2 Conso | |
| K242121 | 2025-03-14 | Monogram Orthopaedics, Inc. | mBôs (Monogram mBôs TKA System) | |
| K242890 | 2025-03-07 | Spineart SA | SPINEART Navigation Instrument System | |
| K242914 | 2025-03-07 | Ecential Robotics | Op.n(TM) Navigation | |
| K243751 | 2025-03-05 | Mako Surgical Corp. | Mako Total Hip Application 5.0 | |
| K243258 | 2025-02-21 | Proprio, Inc. | Paradigm System | |
| K243387 | 2025-01-29 | Gyder Surgical Pty, Ltd. | GYDER® Hip System | |
| K243814 | 2025-01-10 | Globus Medical, Inc. | NuVasive Pulse System | |
| K243481 | 2025-01-06 | THINK Surgical, Inc. | TMINI Miniature Robotic System | |
| K243671 | 2024-12-20 | Globus Medical, Inc. | ExcelsiusGPS® Instruments | |
| K243560 | 2024-12-13 | Remex Medical Corp. | Remex Spine Surgery Navigation Instrument | |
| K243073 | 2024-12-06 | GS Medical Co., Ltd. | AnyPlus Navigated Instruments System | |
| K243285 | 2024-11-15 | THINK Surgical, Inc. | TMINI Miniature Robotic System | FDA |
| K242373 | 2024-11-07 | Mako Surgical Corp. | Mako Shoulder Application (1.0) | |
| K242864 | 2024-10-18 | Orthosoft Inc. (d/b/a) Zimmer CAS | ROSA® Knee System | |
| K240160 | 2024-10-17 | Astura Medical | EGPS Navigated Instruments | |
| K241893 | 2024-09-16 | Medos International SARL | CROSSNAV Navigation Enabled Instruments and UNAS Nav | |
| K241517 | 2024-08-27 | Stryker Leibinger GmbH & Co KG | Q Guidance System; Mako Spine System; | |
| K242264 | 2024-08-23 | THINK Surgical, Inc. | TMINI Miniature Robotic System | |
| K242009 | 2024-08-08 | Kico Knee Innovation Company Pty, Ltd. | 360CAS Knee | |
| K241644 | 2024-08-07 | Spineart SA | SPINEART Navigation Instrument System | |
| K233706 | 2024-08-02 | Nuvasive | Bendini Cloud Application | FDA |
| K233725 | 2024-07-26 | Medivis, Inc. | Spine Navigation System | |
| K241171 | 2024-07-25 | Stryker Leibinger GmbH & Co KG | Spine Guidance Software (Version 5.1); Consolidated | |
| K241130 | 2024-07-24 | Point Robotics MedTech, Inc. | POINT Kinguide Agile Hybrid Navigation System (PSH | |
| K241031 | 2024-07-12 | THINK Surgical, Inc. | TMINI Miniature Robotic System (TMINI 1.1) | |
| K241625 | 2024-07-05 | Remex Medical Corp. | Anatase Navi Disposable Instrument | |
| K233255 | 2024-06-17 | DePuy Synthes | CROSSNAV Navigation Enabled Instruments | |
| K233256 | 2024-06-17 | DePuy Synthes | Robotic Integration Instruments | FDA |
| K240721 | 2024-06-14 | Globus Medical, Inc. | ExcelsiusFlex | |
| K241082 | 2024-06-14 | Innosys Co., Ltd. | INNOVERSE Navigation Instruments | |
| K233254 | 2024-06-14 | DePuy Synthes | TELIGEN System Navigation Ready Instruments | |
| K233228 | 2024-06-14 | Ecential Robotics | Spine Navigation and Robotic-Assistance Device | |
| K241011 | 2024-06-11 | Mako Surgical Corp. | Mako Total Knee Application | FDA |
| K240662 | 2024-06-06 | Stryker Leibinger GmbH & Co KG | Spine Guidance Software (version 5.0); Xia 3/ Serrat | |
| K240951 | 2024-06-06 | Alphatec Spine | Invictus Robotic Navigation Instruments | |
| K240211 | 2024-06-05 | Depuy Ireland UC | VELYS Robotic-Assisted Solution | |
| K240701 | 2024-05-23 | Brainlab AG | Drill Guide; Drill Bit; Spine & Trauma Navigation | |
| K240625 | 2024-05-03 | Providence Medical Technology, Inc. | CORUS Navigation Access System | |
| K233513 | 2024-05-01 | Remex Medical Corp. | Remex Spine Surgery Navigation System II | |
| K240062 | 2024-04-29 | Insight Medical Systems, Inc. | ARVIS® Shoulder | |
| K240568 | 2024-04-29 | Globus Medical, Inc. | DuraPro Oscillating System | FDA |
| K240647 | 2024-04-05 | Zimvie Spine (Zimmer Biomet Spine, Inc | Virage® Navigation System | FDA |
| K233595 | 2024-03-29 | Genesys Spine | Genesys Spine Sacroiliac Joint Fusion System with Na | |
| K234047 | 2024-03-20 | Brainlab AG | Automatic Registration | |
| K240139 | 2024-03-18 | Blue Belt Technologies, Inc. | Real Intelligence CORI | |
| K233542 | 2024-03-14 | Stryker Leibinger GmbH & Co KG | Ortho Guidance Precision Knee Software; Ortho Guidan | |
| K232140 | 2024-03-11 | Ortoma AB | OTS Hip | |
| K230195 | 2024-03-08 | Comerge AG | Neo ADVISE software | |
| K232800 | 2024-02-23 | SI-BONE, Inc. | Navigation Tracking Instruments | |
| K233199 | 2024-02-21 | Orthosoft Inc (D/B/A Zimmer Cas) | ROSA® Shoulder System |
FDA 官方分类页： OLO
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。