510(k) submissions
Filtered by Stereotactic Surgery · showing 1–50 of 68
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K261060 | Navigated LLIF Impactable TrackerSpine Surgery | Tyber Medical, LLCUnited States | Stereotactic Surgery | Class 2 | 2026-05-29 |
| K260011 | Foundation Surgical Navigated Lateral Disc Prep InstrumentsSpine Surgery | Foundation Surgical Group, Inc.United States | Stereotactic Surgery | Class 2 | 2026-04-16 |
| K254158 | SPINEART Navigation Instrument SystemSpine Surgery | Spineart SASwitzerland | Stereotactic Surgery | Class 2 | 2026-04-09 |
| K260601 | REAL INTELLIGENCE™ CORI™Knee Surgery | Blue Belt Technologies, Inc.United States | Stereotactic Surgery | Class 2 | 2026-03-26 |
| K253604 | TiLink-L Navigation InstrumentsNavigation System | SurGenTec, LLCUnited States | Stereotactic Surgery | Class 2 | 2026-03-20 |
| K253444 | EUROPA™ Posterior Cervical Fusion Navigated InstrumentsSpine Surgery | MiRus, LLCUnited States | Stereotactic Surgery | Class 2 | 2026-03-18 |
| K260010 | TMINI® Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2026-03-03 |
| K260222 | Mako Total Knee ApplicationKnee Surgery | Mako Surgical Corp.United States | Stereotactic Surgery | Class 2 | 2026-02-25 |
| 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 MotorSpine Surgery | Stryker Leibinger GmbH & Co KGGermany | Stereotactic Surgery | Class 2 | 2026-02-19 |
| K252058 | ROSA Knee System with UltraSound Imaging Platform (USIP)Knee Surgery | Balmoral Medical, LLCUnited States | Stereotactic Surgery | Class 2 | 2026-02-06 |
| K253661 | TMINI Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2025-12-22 |
| K252841 | REAL INTELLIGENCE™ CORI™ XT (CORI XT)Knee Surgery | Blue Belt Technologies, Inc.United States | Stereotactic Surgery | Class 2 | 2025-12-05 |
| K251314 | Rosa® Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2025-11-13 |
| K252742 | Navigated InstrumentsSpine Surgery | Tyber Medical, LLCUnited States | Stereotactic Surgery | Class 2 | 2025-10-28 |
| K252544 | TMINI Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2025-10-10 |
| K251780 | iGPS Navigation InstrumentsNavigation System | SI-BONE, Inc.United States | Stereotactic Surgery | Class 2 | 2025-09-15 |
| K250877 | TMINI Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2025-06-20 |
| K242464 | Stealth™ Spine Clamps; ModuLeX™ Shank MountsSpine Surgery | Medtronic Navigation, Inc.United States | Stereotactic Surgery | Class 2 | 2025-06-05 |
| K250608 | Mako Total Knee Application (3.0); Hybrid Tip PointerKnee Surgery | Mako Surgical Corp.United States | Stereotactic Surgery | Class 2 | 2025-04-25 |
| K250182 | Innovasis Navigation InstrumentsSpine Surgery | Innovasis, Inc.United States | Stereotactic Surgery | Class 2 | 2025-03-24 |
| K243958 | Consolidated Operating Room Equipment (CORE) 2 ConsoleSpine Surgery | Stryker InstrumentsUnited States | Stereotactic Surgery | Class 2 | 2025-03-21 |
| K242890 | SPINEART Navigation Instrument SystemSpine Surgery | Spineart SASwitzerland | Stereotactic Surgery | Class 2 | 2025-03-07 |
| K243751 | Mako Total Hip Application 5.0Other | Mako Surgical Corp.United States | Stereotactic Surgery | Class 2 | 2025-03-05 |
| K243387 | GYDER® Hip SystemNavigation System | Gyder Surgical Pty, Ltd.Australia | Stereotactic Surgery | Class 2 | 2025-01-29 |
| K243481 | TMINI Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2025-01-06 |
| K243285 | TMINI Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2024-11-15 |
| K242373 | Mako Shoulder Application (1.0)Other | Mako Surgical Corp.United States | Stereotactic Surgery | Class 2 | 2024-11-07 |
| K242264 | TMINI Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2024-08-23 |
| K233725 | Spine Navigation SystemSpine Surgery | Medivis, Inc.United States | Stereotactic Surgery | Class 2 | 2024-07-26 |
| K241031 | TMINI Miniature Robotic System (TMINI 1.1)Knee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2024-07-12 |
| K241082 | INNOVERSE Navigation InstrumentsSpine Surgery | Innosys Co., Ltd.Korea, Republic of | Stereotactic Surgery | Class 2 | 2024-06-14 |
| K233254 | TELIGEN System Navigation Ready InstrumentsSpine Surgery | DePuy SynthesSwitzerland | Stereotactic Surgery | Class 2 | 2024-06-14 |
| K241011 | Mako Total Knee ApplicationKnee Surgery | Mako Surgical Corp.United States | Stereotactic Surgery | Class 2 | 2024-06-11 |
| K240211 | VELYS Robotic-Assisted SolutionKnee Surgery | Depuy Ireland UCIreland | Stereotactic Surgery | Class 2 | 2024-06-05 |
| K232800 | Navigation Tracking InstrumentsSpine Surgery | SI-BONE, Inc.United States | Stereotactic Surgery | Class 2 | 2024-02-23 |
| K233199 | ROSA® Shoulder SystemOther | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2024-02-21 |
| K233299 | ExactechGPS® SystemKnee Surgery | Blue OrthoFrance | Stereotactic Surgery | Class 2 | 2024-01-26 |
| K233227 | VELYS™ Robotic-Assisted SolutionKnee Surgery | Depuy Ireland UCIreland | Stereotactic Surgery | Class 2 | 2023-12-14 |
| K230700 | RIWOtrack Navigation SystemSpine Surgery | Fiagon GmbHUnited States | Stereotactic Surgery | Class 2 | 2023-11-20 |
| K232533 | ROSA Partial Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2023-11-16 |
| K232802 | TMINI™ Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2023-10-12 |
| K231172 | ApolloKneeKnee Surgery | Corin U.S.A. LimitedUnited States | Stereotactic Surgery | Class 2 | 2023-07-26 |
| K230716 | Robotic Graft Delivery InstrumentsSpine Surgery | Medtronic Sofamor Danek, Inc.United States | Stereotactic Surgery | Class 2 | 2023-07-18 |
| K223808 | Zavation Navigation Instrument SystemSpine Surgery | Zavation Medical Products, LLCUnited States | Stereotactic Surgery | Class 2 | 2023-07-12 |
| K230861 | VADER® Pedicle System Navigated InstrumentsSpine Surgery | Icotec AGSwitzerland | Stereotactic Surgery | Class 2 | 2023-06-27 |
| K230369 | EUROPA™ Navigated InstrumentsSpine Surgery | MiRus, LLCUnited States | Stereotactic Surgery | Class 2 | 2023-06-23 |
| K231184 | CD Horizon™ Spinal SystemSpine Surgery | Medtronic Sofamor Danek USA, Inc.United States | Stereotactic Surgery | Class 2 | 2023-05-26 |
| K230989 | Rod Registration FrameSpine Surgery | Nu Vasive, IncorporatedUnited States | Stereotactic Surgery | Class 2 | 2023-05-05 |
| K230880 | CoreLink Navigation InstrumentsSpine Surgery | Corelink, LLCUnited States | Stereotactic Surgery | Class 2 | 2023-05-02 |
| K230202 | TMINI™ Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2023-04-25 |