| Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) (K261410) | Suite 201, National Innovation Centre | 2026-07-30 |
| SPINEART Navigation Instrument System (K261205) | Spineart SA | 2026-07-29 |
| TMINI Miniature Robotic System (K261024) | THINK Surgical, Inc. | 2026-07-24 |
| Ion-L Navigated Instruments (K262121) | SurGenTec, LLC | 2026-07-24 |
| Op.n™ Spine Navigation and Robotic Guidance (K261113) | Ecential Robotics | 2026-07-22 |
| OTS Hip (K261852) | Ortoma AB | 2026-07-01 |
| VERTICALE® Navigation Instruments (K253921) | Silony Medical GmbH | 2026-06-26 |
| VELYS™ Robotic-Assisted Solution (K260480) | Depuy Ireland UC | 2026-06-25 |
| Dynamis Robotic Surgical System (K260369) | LEM Surgical AG | 2026-06-20 |
| CORUS™ Navigation System-GN (K261665) | Providence Medical Technology, Inc. | 2026-06-18 |
| SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments (K260571) | Life Spine, Inc. | 2026-06-02 |
| Navigated LLIF Impactable Tracker (K261060) | Tyber Medical, LLC | 2026-05-29 |
| CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody (K254157) | Medos International SARL | 2026-05-26 |
| Ion-C Navigation Instruments (K260329) | SurGenTec, LLC | 2026-05-22 |
| ROSA® Shoulder System (K260582) | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026-05-21 |
| Pytheas Your Guided Trajectory (K252880) | Pytheas Navigation Sas | 2026-05-11 |
| Foundation Surgical Navigated Lateral Disc Prep Instruments (K260011) | Foundation Surgical Group, Inc. | 2026-04-16 |
| SPINEART Navigation Instrument System (K254158) | Spineart SA | 2026-04-09 |
| SYMPHONY Navigation Ready Instruments (K260240) | Medos International SARL | 2026-03-27 |
| REAL INTELLIGENCE™ CORI™ (K260601) | Blue Belt Technologies, Inc. | 2026-03-26 |
| CUVIS-joint (CJ150) (K252037) | Curexo, Inc. | 2026-03-25 |
| TiLink-L Navigation Instruments (K253604) | SurGenTec, LLC | 2026-03-20 |
| EUROPA™ Posterior Cervical Fusion Navigated Instruments (K253444) | MiRus, LLC | 2026-03-18 |
| Q Pedicle Instruments (K260546) | K2m, Inc. | 2026-03-17 |
| TMINI® Miniature Robotic System (K260010) | THINK Surgical, Inc. | 2026-03-03 |
| Mako Total Knee Application (K260222) | Mako Surgical Corp. | 2026-02-25 |
| “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set (K252989) | Point Robotics MedTech, Inc. | 2026-02-20 |
| Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) (K252597) | Alphatec Spine, Inc. | 2026-02-19 |
| 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 (K253623) | Stryker Leibinger GmbH & Co KG | 2026-02-19 |
| VERTICALE GPS Instruments (K254148) | Silony Medical GmbH | 2026-02-19 |
| Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application (K253381) | Medtronic Navigation, Inc. | 2026-02-12 |
| Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories (K252871) | Stryker Leibinger GmbH & Co KG | 2026-02-06 |
| Q Interbody Instruments (K252873) | K2m, Inc. | 2026-02-06 |
| ROSA Knee System with UltraSound Imaging Platform (USIP) (K252058) | Balmoral Medical, LLC | 2026-02-06 |
| Navigation Module of the Cortium® System (K252087) | Ulrich Medical USA, Inc. | 2026-02-03 |
| POINT Kinguide Agile Robotic Arm Surgical Stereotactic System (K252755) | Point Robotics MedTech, Inc. | 2026-01-23 |
| DYNAMIS™ Navigation System (K252962) | Promethean Restorative, LLC | 2026-01-12 |
| TMINI Miniature Robotic System (K253661) | THINK Surgical, Inc. | 2025-12-22 |
| Paradigm System (K252950) | Proprio, Inc. | 2025-12-15 |
| REAL INTELLIGENCE™ CORI™ XT (CORI XT) (K252841) | Blue Belt Technologies, Inc. | 2025-12-05 |
| Spineology Navigation Instruments (K251943) | Spineology, Inc. | 2025-12-04 |
| Rosa® Knee System (K251314) | Orthosoft Inc. (d/b/a) Zimmer CAS | 2025-11-13 |
| ExcelsiusGPS™ Instruments (K250599) | Globus Medical, Inc. | 2025-11-05 |
| Firebird SI Navigation System (K252088) | Orthofix US, LLC | 2025-10-31 |
| Navigated Instruments (K252742) | Tyber Medical, LLC | 2025-10-28 |
| OsteoCentric Navigated Instruments System (K250520) | Osteocentric Technologies, Inc. | 2025-10-27 |
| StealthStation S8 Spine Software (K251282) | Medtronic Navigation, Inc. | 2025-10-17 |
| TMINI Miniature Robotic System (K252544) | THINK Surgical, Inc. | 2025-10-10 |
| RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer (K251971) | Stryker Instruments | 2025-09-25 |
| iGPS Navigation Instruments (K251780) | SI-BONE, Inc. | 2025-09-15 |
| Spine & Trauma Navigation Instruments (K252562) | Brainlab AG | 2025-09-12 |
| Mazor X System / Mazor X Stealth Edition (K251316) | Mazor Robotics , Ltd. | 2025-09-11 |
| Evolution Spine Navigation Instruments (K250167) | Evolution Spine | 2025-08-18 |
| CORUS™ Navigation System-GX (K251060) | Providence Medical Technology, Inc. | 2025-07-30 |
| Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) (K251073) | Innovasis, Inc. | 2025-07-23 |
| TMINI Miniature Robotic System (K250877) | THINK Surgical, Inc. | 2025-06-20 |
| SPINEART Navigation Instrument System (K242933) | Spineart SA | 2025-06-18 |
| Stealth™ Spine Clamps; ModuLeX™ Shank Mounts (K242464) | Medtronic Navigation, Inc. | 2025-06-05 |
| Paradigm System (K250879) | Proprio, Inc. | 2025-06-04 |
| Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II (K251315) | Remex Medical Corp. | 2025-05-29 |
| OTS Hip (K250086) | Ortoma AB | 2025-05-16 |
| Altus Spine Navigation System (K243419) | Altus Partners, LLC | 2025-05-08 |
| Mako Total Knee Application (3.0); Hybrid Tip Pointer (K250608) | Mako Surgical Corp. | 2025-04-25 |
| Dynamis Robotic Surgical System (K243326) | LEM Surgical AG | 2025-04-23 |
| Medyssey Navigation System (K242806) | Medyssey Co, Ltd. | 2025-04-16 |
| Salvo® Robotic Navigation Instruments (K243514) | Spine Wave, Inc. | 2025-04-03 |
| FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments (K243659) | SeaSpine Orthopedics Corporation | 2025-04-02 |
| Innovasis Navigation Instruments (K250182) | Innovasis, Inc. | 2025-03-24 |
| Consolidated Operating Room Equipment (CORE) 2 Console (K243958) | Stryker Instruments | 2025-03-21 |
| mBôs (Monogram mBôs TKA System) (K242121) | Monogram Orthopaedics, Inc. | 2025-03-14 |
| Op.n(TM) Navigation (K242914) | Ecential Robotics | 2025-03-07 |
| SPINEART Navigation Instrument System (K242890) | Spineart SA | 2025-03-07 |
| Mako Total Hip Application 5.0 (K243751) | Mako Surgical Corp. | 2025-03-05 |
| Paradigm System (K243258) | Proprio, Inc. | 2025-02-21 |
| GYDER® Hip System (K243387) | Gyder Surgical Pty, Ltd. | 2025-01-29 |
| NuVasive Pulse System (K243814) | Globus Medical, Inc. | 2025-01-10 |
| TMINI Miniature Robotic System (K243481) | THINK Surgical, Inc. | 2025-01-06 |
| ExcelsiusGPS® Instruments (K243671) | Globus Medical, Inc. | 2024-12-20 |
| Remex Spine Surgery Navigation Instrument (K243560) | Remex Medical Corp. | 2024-12-13 |
| AnyPlus Navigated Instruments System (K243073) | GS Medical Co., Ltd. | 2024-12-06 |
| TMINI Miniature Robotic System (K243285) | THINK Surgical, Inc. | 2024-11-15 |
| Mako Shoulder Application (1.0) (K242373) | Mako Surgical Corp. | 2024-11-07 |
| ROSA® Knee System (K242864) | Orthosoft Inc. (d/b/a) Zimmer CAS | 2024-10-18 |
| EGPS Navigated Instruments (K240160) | Astura Medical | 2024-10-17 |
| CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays (K241893) | Medos International SARL | 2024-09-16 |
| Q Guidance System; Mako Spine System; (K241517) | Stryker Leibinger GmbH & Co KG | 2024-08-27 |
| TMINI Miniature Robotic System (K242264) | THINK Surgical, Inc. | 2024-08-23 |
| 360CAS Knee (K242009) | Kico Knee Innovation Company Pty, Ltd. | 2024-08-08 |
| SPINEART Navigation Instrument System (K241644) | Spineart SA | 2024-08-07 |
| Bendini Cloud Application (K233706) | Nuvasive | 2024-08-02 |
| Spine Navigation System (K233725) | Medivis, Inc. | 2024-07-26 |
| 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 (K241171) | Stryker Leibinger GmbH & Co KG | 2024-07-25 |
| “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) (K241130) | Point Robotics MedTech, Inc. | 2024-07-24 |
| TMINI Miniature Robotic System (TMINI 1.1) (K241031) | THINK Surgical, Inc. | 2024-07-12 |
| Anatase Navi Disposable Instrument (K241625) | Remex Medical Corp. | 2024-07-05 |
| Robotic Integration Instruments (K233256) | DePuy Synthes | 2024-06-17 |
| CROSSNAV Navigation Enabled Instruments (K233255) | DePuy Synthes | 2024-06-17 |
| ExcelsiusFlex™ (K240721) | Globus Medical, Inc. | 2024-06-14 |
| TELIGEN System Navigation Ready Instruments (K233254) | DePuy Synthes | 2024-06-14 |
| INNOVERSE Navigation Instruments (K241082) | Innosys Co., Ltd. | 2024-06-14 |