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 |
|---|---|---|---|
| K262257 | Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine | Brainlab SE | 2026-09-30 |
| K262506 | Remex Spine Surgery Navigation - Universal Instruments | Remex Medical Corp. | 2026-08-20 |
| K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) | Suite 201, National Innovation Centre | 2026-07-30 |
| K261205 | SPINEART Navigation Instrument System | Spineart SA | 2026-07-29 |
| K261024 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2026-07-24 |
| K262121 | Ion-L Navigated Instruments | SurGenTec, LLC | 2026-07-24 |
| K261113 | Op.n™ Spine Navigation and Robotic Guidance | Ecential Robotics | 2026-07-22 |
| K261852 | OTS Hip | Ortoma AB | 2026-07-01 |
| K253921 | VERTICALE® Navigation Instruments | Silony Medical GmbH | 2026-06-26 |
| K260480 | VELYS™ Robotic-Assisted Solution | Depuy Ireland UC | 2026-06-25 |
| K260369 | Dynamis Robotic Surgical System | LEM Surgical AG | 2026-06-20 |
| K261665 | CORUS™ Navigation System-GN | Providence Medical Technology, Inc. | 2026-06-18 |
| K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | Life Spine, Inc. | 2026-06-02 |
| K261060 | Navigated LLIF Impactable Tracker | Tyber Medical, LLC | 2026-05-29 |
| K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | Medos International SARL | 2026-05-26 |
| 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 |
| K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) | Alphatec Spine, Inc. | 2026-02-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00885556924327 | Real Intelligence | Smith & Nephew, Inc. | 2026-10-08 |
| 00810055525287 | Onyx 6.5 mm Navigated Awl Tip Tap | Si-Bone Inc. | 2026-09-30 |
| 00810055526321 | Onyx iGPS Driver | Si-Bone Inc. | 2026-09-30 |
| 00810055526314 | Onyx iGPS Awl Tip Tap 7.5mm | Si-Bone Inc. | 2026-09-30 |
| 00810055526307 | Onyx iGPS Awl Tip Tap 6.5mm | Si-Bone Inc. | 2026-09-30 |
| 00810055526291 | Onyx iGPS Awl Tip Tap 5.5mm | Si-Bone Inc. | 2026-09-30 |
| 00810055526284 | Onyx iGPS Awl Tip Tap 4.5mm | Si-Bone Inc. | 2026-09-30 |
| 00810055525966 | Onyx Navigated Locking Driver, Cannulated | Si-Bone Inc. | 2026-09-30 |
| 00810055525720 | Onyx Navigated Locking Driver | Si-Bone Inc. | 2026-09-30 |
| 00810055525294 | Onyx 7.5 mm Navigated Awl Tip Tap | Si-Bone Inc. | 2026-09-30 |
| 00810055525270 | Onyx 5.5 mm Navigated Awl Tip Tap | Si-Bone Inc. | 2026-09-30 |
| 00810055525263 | Onyx 4.5 mm Navigated Awl Tip Tap | Si-Bone Inc. | 2026-09-30 |
| 00810055525256 | Onyx 7.5mm Navigated Cannulated Tap | Si-Bone Inc. | 2026-09-30 |
| 00810055525249 | Onyx 6.5mm Navigated Cannulated Tap | Si-Bone Inc. | 2026-09-30 |
| 00810055525232 | Onyx 5.5mm Navigated Cannulated Tap | Si-Bone Inc. | 2026-09-30 |
| 00810055525225 | Onyx 4.5 mm Navigated Cannulated Tap | Si-Bone Inc. | 2026-09-30 |
| 00810131884079 | TiLink-L Rescue Impact Cap | Surgentec, LLC | 2026-09-25 |
| 00810131884086 | TiLink-L Rescue screw Drill bit – 10.5mm | Surgentec, LLC | 2026-09-25 |
| 00810131884857 | TiLink-L Sterilization Tray – Double Stack | Surgentec, LLC | 2026-09-25 |
| 00810131884864 | TiLink-L Rescue Caddy | Surgentec, LLC | 2026-09-25 |
| 00810076335322 | Momentum | Ulrich Medical Usa, Inc. | 2026-09-25 |
| 00810131884055 | TiLink-L Rescue Drill Guide | Surgentec, LLC | 2026-09-25 |
| 00810131884062 | TiLink-L Rescue Dilator | Surgentec, LLC | 2026-09-25 |
| 04546540717443 | ORTHOMAP | Stryker Leibinger GmbH & Co. KG | 2017-12-12 |
| 00848486002534 | VIZADISC | MAKO SURGICAL CORP. | 2016-09-24 |
| 00848486001414 | VIZADISC | MAKO SURGICAL CORP. | 2016-09-24 |
| 07613327064964 | NAVIGATED XIA 3 | Stryker Corporation | 2016-09-24 |
| 07613327115017 | SPINEMAP | Stryker Leibinger GmbH & Co. KG | 2016-08-24 |
| 07613327114935 | SPINEMAP | Stryker Leibinger GmbH & Co. KG | 2016-08-24 |
| 07613327114898 | SPINEMAP | Stryker Leibinger GmbH & Co. KG | 2016-08-24 |