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 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262257 | Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine | Brainlab SE | 2026-09-30 | Traditional | PDF ↗ |
| K262506 | Remex Spine Surgery Navigation - Universal Instruments | Remex Medical Corp. | 2026-08-20 | Special | PDF ↗ |
| K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) | Suite 201, National Innovation Centre | 2026-07-30 | Traditional | PDF ↗ |
| K261205 | SPINEART Navigation Instrument System | Spineart SA | 2026-07-29 | Traditional | PDF ↗ |
| K262121 | Ion-L Navigated Instruments | SurGenTec, LLC | 2026-07-24 | Special | PDF ↗ |
| K261024 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2026-07-24 | Traditional | PDF ↗ |
| K261113 | Op.n Spine Navigation and Robotic Guidance | Ecential Robotics | 2026-07-22 | Traditional | PDF ↗ |
| K261852 | OTS Hip | Ortoma AB | 2026-07-01 | Special | PDF ↗ |
| K253921 | VERTICALE® Navigation Instruments | Silony Medical GmbH | 2026-06-26 | Traditional | PDF ↗ |
| K260480 | VELYS Robotic-Assisted Solution | Depuy Ireland UC | 2026-06-25 | Traditional | PDF ↗ |
| K260369 | Dynamis Robotic Surgical System | LEM Surgical AG | 2026-06-20 | Traditional | PDF ↗ |
| K261665 | CORUS Navigation System-GN | Providence Medical Technology, Inc. | 2026-06-18 | Special | PDF ↗ |
| K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | Life Spine, Inc. | 2026-06-02 | Traditional | PDF ↗ |
| K261060 | Navigated LLIF Impactable Tracker | Tyber Medical, LLC | 2026-05-29 | Traditional | PDF ↗ |
| K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | Medos International SARL | 2026-05-26 | Traditional | PDF ↗ |
| K260329 | Ion-C Navigation Instruments | SurGenTec, LLC | 2026-05-22 | Traditional | PDF ↗ |
| K260582 | ROSA® Shoulder System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026-05-21 | Traditional | PDF ↗ |
| K252880 | Pytheas Your Guided Trajectory | Pytheas Navigation Sas | 2026-05-11 | Traditional | PDF ↗ |
| K260011 | Foundation Surgical Navigated Lateral Disc Prep Instruments | Foundation Surgical Group, Inc. | 2026-04-16 | Traditional | PDF ↗ |
| K254158 | SPINEART Navigation Instrument System | Spineart SA | 2026-04-09 | Special | PDF ↗ |
| K260240 | SYMPHONY Navigation Ready Instruments | Medos International SARL | 2026-03-27 | Traditional | PDF ↗ |
| K260601 | REAL INTELLIGENCE CORI | Blue Belt Technologies, Inc. | 2026-03-26 | Special | PDF ↗ |
| K252037 | CUVIS-joint (CJ150) | Curexo, Inc. | 2026-03-25 | Traditional | PDF ↗ |
| K253604 | TiLink-L Navigation Instruments | SurGenTec, LLC | 2026-03-20 | Traditional | PDF ↗ |
| K253444 | EUROPA Posterior Cervical Fusion Navigated Instruments | MiRus, LLC | 2026-03-18 | Traditional | PDF ↗ |
| K260546 | Q Pedicle Instruments | K2m, Inc. | 2026-03-17 | Special | PDF ↗ |
| K260010 | TMINI® Miniature Robotic System | THINK Surgical, Inc. | 2026-03-03 | Traditional | PDF ↗ |
| K260222 | Mako Total Knee Application | Mako Surgical Corp. | 2026-02-25 | Special | PDF ↗ |
| K252989 | POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set | Point Robotics MedTech, Inc. | 2026-02-20 | Traditional | PDF ↗ |
| K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor | Stryker Leibinger GmbH & Co KG | 2026-02-19 | Traditional | PDF ↗ |
| K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) | Alphatec Spine, Inc. | 2026-02-19 | Traditional | PDF ↗ |
| K254148 | VERTICALE GPS Instruments | Silony Medical GmbH | 2026-02-19 | Traditional | PDF ↗ |
| K253381 | Stealth AXiS Surgical System with Stealth AXiS Spine clinical application | Medtronic Navigation, Inc. | 2026-02-12 | Traditional | PDF ↗ |
| K252058 | ROSA Knee System with UltraSound Imaging Platform (USIP) | Balmoral Medical, LLC | 2026-02-06 | Traditional | PDF ↗ |
| K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories | Stryker Leibinger GmbH & Co KG | 2026-02-06 | Traditional | PDF ↗ |
| K252873 | Q Interbody Instruments | K2m, Inc. | 2026-02-06 | Traditional | PDF ↗ |
| K252087 | Navigation Module of the Cortium® System | Ulrich Medical USA, Inc. | 2026-02-03 | Traditional | PDF ↗ |
| K252755 | POINT Kinguide Agile Robotic Arm Surgical Stereotactic System | Point Robotics MedTech, Inc. | 2026-01-23 | Traditional | PDF ↗ |
| K252962 | DYNAMIS Navigation System | Promethean Restorative, LLC | 2026-01-12 | Traditional | PDF ↗ |
| K253661 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2025-12-22 | Special | PDF ↗ |
| K252950 | Paradigm System | Proprio, Inc. | 2025-12-15 | Traditional | PDF ↗ |
| K252841 | REAL INTELLIGENCE CORI XT (CORI XT) | Blue Belt Technologies, Inc. | 2025-12-05 | Traditional | PDF ↗ |
| K251943 | Spineology Navigation Instruments | Spineology, Inc. | 2025-12-04 | Special | PDF ↗ |
| K251314 | Rosa® Knee System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2025-11-13 | Traditional | PDF ↗ |
| K250599 | ExcelsiusGPS Instruments | Globus Medical, Inc. | 2025-11-05 | Traditional | PDF ↗ |
| K252088 | Firebird SI Navigation System | Orthofix US, LLC | 2025-10-31 | Traditional | PDF ↗ |
| K252742 | Navigated Instruments | Tyber Medical, LLC | 2025-10-28 | Traditional | PDF ↗ |
| K250520 | OsteoCentric Navigated Instruments System | Osteocentric Technologies, Inc. | 2025-10-27 | Traditional | PDF ↗ |
| K251282 | StealthStation S8 Spine Software | Medtronic Navigation, Inc. | 2025-10-17 | Traditional | PDF ↗ |
| K252544 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2025-10-10 | Traditional | PDF ↗ |
| K251971 | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer | Stryker Instruments | 2025-09-25 | Traditional | PDF ↗ |
| K251780 | iGPS Navigation Instruments | SI-BONE, Inc. | 2025-09-15 | Traditional | PDF ↗ |
| K252562 | Spine & Trauma Navigation Instruments | Brainlab AG | 2025-09-12 | Special | PDF ↗ |
| K251316 | Mazor X System / Mazor X Stealth Edition | Mazor Robotics , Ltd. | 2025-09-11 | Traditional | PDF ↗ |
| K250167 | Evolution Spine Navigation Instruments | Evolution Spine | 2025-08-18 | Traditional | PDF ↗ |
| K251060 | CORUS Navigation System-GX | Providence Medical Technology, Inc. | 2025-07-30 | Traditional | PDF ↗ |
| K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) | Innovasis, Inc. | 2025-07-23 | Traditional | PDF ↗ |
| K250877 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2025-06-20 | Traditional | PDF ↗ |
| K242933 | SPINEART Navigation Instrument System | Spineart SA | 2025-06-18 | Traditional | PDF ↗ |
| K242464 | Stealth Spine Clamps; ModuLeX Shank Mounts | Medtronic Navigation, Inc. | 2025-06-05 | Traditional | PDF ↗ |
| K250879 | Paradigm System | Proprio, Inc. | 2025-06-04 | Traditional | PDF ↗ |
| K251315 | Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II | Remex Medical Corp. | 2025-05-29 | Special | PDF ↗ |
| K250086 | OTS Hip | Ortoma AB | 2025-05-16 | Traditional | PDF ↗ |
| K243419 | Altus Spine Navigation System | Altus Partners, LLC | 2025-05-08 | Traditional | PDF ↗ |
| K250608 | Mako Total Knee Application (3.0); Hybrid Tip Pointer | Mako Surgical Corp. | 2025-04-25 | Traditional | PDF ↗ |
| K243326 | Dynamis Robotic Surgical System | LEM Surgical AG | 2025-04-23 | Traditional | PDF ↗ |
| K242806 | Medyssey Navigation System | Medyssey Co, Ltd. | 2025-04-16 | Traditional | PDF ↗ |
| K243514 | Salvo® Robotic Navigation Instruments | Spine Wave, Inc. | 2025-04-03 | Traditional | PDF ↗ |
| K243659 | FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments | SeaSpine Orthopedics Corporation | 2025-04-02 | Traditional | PDF ↗ |
| K250182 | Innovasis Navigation Instruments | Innovasis, Inc. | 2025-03-24 | Traditional | PDF ↗ |
| K243958 | Consolidated Operating Room Equipment (CORE) 2 Console | Stryker Instruments | 2025-03-21 | Traditional | PDF ↗ |
| K242121 | mBôs (Monogram mBôs TKA System) | Monogram Orthopaedics, Inc. | 2025-03-14 | Traditional | PDF ↗ |
| K242914 | Op.n(TM) Navigation | Ecential Robotics | 2025-03-07 | Traditional | PDF ↗ |
| K242890 | SPINEART Navigation Instrument System | Spineart SA | 2025-03-07 | Traditional | PDF ↗ |
| K243751 | Mako Total Hip Application 5.0 | Mako Surgical Corp. | 2025-03-05 | Traditional | PDF ↗ |
| K243258 | Paradigm System | Proprio, Inc. | 2025-02-21 | Traditional | PDF ↗ |
| K243387 | GYDER® Hip System | Gyder Surgical Pty, Ltd. | 2025-01-29 | Traditional | PDF ↗ |
| K243814 | NuVasive Pulse System | Globus Medical, Inc. | 2025-01-10 | Special | PDF ↗ |
| K243481 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2025-01-06 | Traditional | PDF ↗ |
| K243671 | ExcelsiusGPS® Instruments | Globus Medical, Inc. | 2024-12-20 | Special | PDF ↗ |
| K243560 | Remex Spine Surgery Navigation Instrument | Remex Medical Corp. | 2024-12-13 | Special | PDF ↗ |
| K243073 | AnyPlus Navigated Instruments System | GS Medical Co., Ltd. | 2024-12-06 | Traditional | PDF ↗ |
| K243285 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2024-11-15 | Special | PDF ↗ |
| K242373 | Mako Shoulder Application (1.0) | Mako Surgical Corp. | 2024-11-07 | Traditional | PDF ↗ |
| K242864 | ROSA® Knee System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2024-10-18 | Special | PDF ↗ |
| K240160 | EGPS Navigated Instruments | Astura Medical | 2024-10-17 | Traditional | PDF ↗ |
| K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays | Medos International SARL | 2024-09-16 | Traditional | PDF ↗ |
| K241517 | Q Guidance System; Mako Spine System; | Stryker Leibinger GmbH & Co KG | 2024-08-27 | Traditional | PDF ↗ |
| K242264 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2024-08-23 | Special | PDF ↗ |
| K242009 | 360CAS Knee | Kico Knee Innovation Company Pty, Ltd. | 2024-08-08 | Special | PDF ↗ |
| K241644 | SPINEART Navigation Instrument System | Spineart SA | 2024-08-07 | Special | PDF ↗ |
| K233706 | Bendini Cloud Application | Nuvasive | 2024-08-02 | Traditional | PDF ↗ |
| K233725 | Spine Navigation System | Medivis, Inc. | 2024-07-26 | Traditional | PDF ↗ |
| 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 Accessories | Stryker Leibinger GmbH & Co KG | 2024-07-25 | Traditional | PDF ↗ |
| K241130 | POINT Kinguide Agile Hybrid Navigation System (PSHF01-000) | Point Robotics MedTech, Inc. | 2024-07-24 | Traditional | PDF ↗ |
| K241031 | TMINI Miniature Robotic System (TMINI 1.1) | THINK Surgical, Inc. | 2024-07-12 | Traditional | PDF ↗ |
| K241625 | Anatase Navi Disposable Instrument | Remex Medical Corp. | 2024-07-05 | Special | PDF ↗ |
| K233256 | Robotic Integration Instruments | DePuy Synthes | 2024-06-17 | Traditional | PDF ↗ |
| K233255 | CROSSNAV Navigation Enabled Instruments | DePuy Synthes | 2024-06-17 | Traditional | PDF ↗ |
| K241082 | INNOVERSE Navigation Instruments | Innosys Co., Ltd. | 2024-06-14 | Traditional | PDF ↗ |
Product code OLO · Class II · Neurology. Data: openFDA.