OLO · Orthopedic Stereotaxic Instrument
Neurology · 21 CFR 882.4560 · Class 2
Overview
| Product Code | OLO |
|---|---|
| Device Name | Orthopedic Stereotaxic Instrument |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 423)
Showing 20 most recent of 423 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260011 | Foundation Surgical Navigated Lateral Disc Prep Instruments | Foundation Surgical Group, Inc. | Apr 16, 2026 | SESE |
| K254158 | SPINEART Navigation Instrument System | Spineart SA | Apr 9, 2026 | SESE |
| K260240 | SYMPHONY Navigation Ready Instruments | Medos International SARL | Mar 27, 2026 | SESE |
| K260601 | REAL INTELLIGENCE CORI | Blue Belt Technologies, Inc. | Mar 26, 2026 | SESE |
| K252037 | CUVIS-joint (CJ150) | Curexo, Inc. | Mar 25, 2026 | SESE |
| K253604 | TiLink-L Navigation Instruments | SurGenTec, LLC | Mar 20, 2026 | SESE |
| K253444 | EUROPA Posterior Cervical Fusion Navigated Instruments | MiRus, LLC | Mar 18, 2026 | SESE |
| K260546 | Q Pedicle Instruments | K2m, Inc. | Mar 17, 2026 | SESE |
| K260010 | TMINI® Miniature Robotic System | THINK Surgical, Inc. | Mar 3, 2026 | SESE |
| K260222 | Mako Total Knee Application | Mako Surgical Corp. | Feb 25, 2026 | SESE |
| K252989 | POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set | Point Robotics MedTech, Inc. | Feb 20, 2026 | SESE |
| K254148 | VERTICALE GPS Instruments | Silony Medical GmbH | Feb 19, 2026 | SESE |
| 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 | Feb 19, 2026 | SESE |
| K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) | Alphatec Spine, Inc. | Feb 19, 2026 | SESE |
| K253381 | Stealth AXiS Surgical System with Stealth AXiS Spine clinical application | Medtronic Navigation, Inc. | Feb 12, 2026 | SESE |
| K252873 | Q Interbody Instruments | K2m, Inc. | Feb 6, 2026 | SESE |
| K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories | Stryker Leibinger GmbH & Co KG | Feb 6, 2026 | SESE |
| K252058 | ROSA Knee System with UltraSound Imaging Platform (USIP) | Balmoral Medical, LLC | Feb 6, 2026 | SESE |
| K252087 | Navigation Module of the Cortium® System | Ulrich Medical USA, Inc. | Feb 3, 2026 | SESE |
| K252755 | POINT Kinguide Agile Robotic Arm Surgical Stereotactic System | Point Robotics MedTech, Inc. | Jan 23, 2026 | SESE |
Top Applicants
- Brainlab AG — 21 clearances
- Mako Surgical Corp. — 19 clearances
- Blue Belt Technologies, Inc. — 18 clearances
- THINK Surgical, Inc. — 18 clearances
- Medtronic Sofamor Danek USA, Inc. — 15 clearances
