Product code OLO
- Device name
- Orthopedic Stereotaxic Instrument
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.4560
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260329 | Ion-C Navigation Instruments | SurGenTec, LLC | 2026-05-22 |
| K260582 | ROSA® Shoulder System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026-05-21 |
| K252880 | Pytheas Your Guided Trajectory | Pytheas Navigation Sas | 2026-05-11 |
| K260011 | Foundation Surgical Navigated Lateral Disc Prep Instruments | Foundation Surgical Group, Inc. | 2026-04-16 |
| K254158 | SPINEART Navigation Instrument System | Spineart SA | 2026-04-09 |
| K260240 | SYMPHONY Navigation Ready Instruments | Medos International SARL | 2026-03-27 |
| K260601 | REAL INTELLIGENCE™ CORI™ | Blue Belt Technologies, Inc. | 2026-03-26 |
| K252037 | CUVIS-joint (CJ150) | Curexo, Inc. | 2026-03-25 |
| K253604 | TiLink-L Navigation Instruments | SurGenTec, LLC | 2026-03-20 |
| K253444 | EUROPA™ Posterior Cervical Fusion Navigated Instruments | MiRus, LLC | 2026-03-18 |
| K260546 | Q Pedicle Instruments | K2m, Inc. | 2026-03-17 |
| K260010 | TMINI® Miniature Robotic System | THINK Surgical, Inc. | 2026-03-03 |
| K260222 | Mako Total Knee Application | Mako Surgical Corp. | 2026-02-25 |
| K252989 | “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set | Point Robotics MedTech, Inc. | 2026-02-20 |
| K254148 | VERTICALE GPS Instruments | Silony Medical GmbH | 2026-02-19 |
| 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; Maest... | Stryker Leibinger GmbH & Co KG | 2026-02-19 |
| K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) | Alphatec Spine, Inc. | 2026-02-19 |
| K253381 | Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application | Medtronic Navigation, Inc. | 2026-02-12 |
| K252873 | Q Interbody Instruments | K2m, Inc. | 2026-02-06 |
| K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories | Stryker Leibinger GmbH & Co KG | 2026-02-06 |
| K252058 | ROSA Knee System with UltraSound Imaging Platform (USIP) | Balmoral Medical, LLC | 2026-02-06 |
| K252087 | Navigation Module of the Cortium® System | Ulrich Medical USA, Inc. | 2026-02-03 |
| K252755 | POINT Kinguide Agile Robotic Arm Surgical Stereotactic System | Point Robotics MedTech, Inc. | 2026-01-23 |
| K252962 | DYNAMIS™ Navigation System | Promethean Restorative, LLC | 2026-01-12 |
| K253661 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2025-12-22 |
| K252950 | Paradigm System | Proprio, Inc. | 2025-12-15 |
| K252841 | REAL INTELLIGENCE™ CORI™ XT (CORI XT) | Blue Belt Technologies, Inc. | 2025-12-05 |
| K251943 | Spineology Navigation Instruments | Spineology, Inc. | 2025-12-04 |
| K251314 | Rosa® Knee System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2025-11-13 |
| K250599 | ExcelsiusGPS™ Instruments | Globus Medical, Inc. | 2025-11-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10885862656124 | Newton | Exactech, Inc. | 2026-05-27 |
| 10885862656131 | Newton | Exactech, Inc. | 2026-05-27 |
| 10885862656148 | Newton | Exactech, Inc. | 2026-05-27 |
| 10885862656155 | Newton | Exactech, Inc. | 2026-05-27 |
| 10885862656162 | Newton | Exactech, Inc. | 2026-05-27 |
| 10885862656179 | Newton | Exactech, Inc. | 2026-05-27 |
| 10885862656117 | Newton | Exactech, Inc. | 2026-05-27 |
| 07613327595543 | Mako | MAKO SURGICAL CORP. | 2026-05-21 |
| 07613327594829 | Common Shoulder Driver | MAKO SURGICAL CORP. | 2026-05-21 |
| 07613327620306 | N/A | Stryker Leibinger GmbH & Co. KG | 2025-10-28 |
| 07613327579864 | N/A | Stryker Leibinger GmbH & Co. KG | 2025-10-13 |
| 07613327627558 | RPS | STRYKER CORPORATION | 2025-10-10 |
| 07613252196259 | FLUOROMAP | Stryker Leibinger GmbH & Co. KG | 2025-01-28 |
| 07613327592979 | CORE | STRYKER CORPORATION | 2024-08-23 |
| 07613327551938 | N/A | Stryker Leibinger GmbH & Co. KG | 2022-07-26 |
| 07613327304466 | NA | STRYKER CORPORATION | 2018-09-24 |
| 07613327298505 | CORE | STRYKER CORPORATION | 2018-01-08 |
| 07613327004175 | STRYKER NAV3I | Stryker Leibinger GmbH & Co. KG | 2017-12-12 |
| 07613252450108 | ORTHOMAP | Stryker Leibinger GmbH & Co. KG | 2017-12-12 |
| 07613327114782 | NAVSUITE | Stryker Leibinger GmbH & Co. KG | 2017-12-12 |
| 07613327004250 | ORTHOMAP | Stryker Leibinger GmbH & Co. KG | 2017-12-12 |
| 07613252450115 | ORTHOMAP | Stryker Leibinger GmbH & Co. KG | 2017-12-12 |
| 07613327294644 | N/A | STRYKER CORPORATION | 2017-07-12 |
| 07613327294910 | N/A | STRYKER CORPORATION | 2017-06-01 |
| 07613327294989 | N/A | STRYKER CORPORATION | 2017-01-03 |
| 07613327294842 | N/A | STRYKER CORPORATION | 2017-01-03 |
| 07613327294835 | N/A | STRYKER CORPORATION | 2017-01-03 |
| 07613154028177 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613153100263 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613153045250 | NA | Stryker Leibinger GmbH & Co. KG | 2016-08-24 |