OLO — Orthopedic Stereotaxic Instrument Class II
Classification Details
- Product Code
- OLO
- Device Class
- Class II
- Regulation Number
- 882.4560
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Neurology
- Implant
- No
Definition
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260010 | think surgical | TMINI® Miniature Robotic System | March 3, 2026 |
| K260222 | mako surgical | Mako Total Knee Application | February 25, 2026 |
| K252989 | point robotics medtech | POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set | February 20, 2026 |
| K254148 | silony medical | VERTICALE GPS Instruments | February 19, 2026 |
| K252597 | alphatec spine | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For U | February 19, 2026 |
| K253623 | stryker leibinger gmbh and co kg | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Upda | February 19, 2026 |
| K253381 | medtronic navigation | Stealth AXiS Surgical System with Stealth AXiS Spine clinical application | February 12, 2026 |
| K252058 | balmoral medical | ROSA Knee System with UltraSound Imaging Platform (USIP) | February 6, 2026 |
| K252871 | stryker leibinger gmbh and co kg | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite | February 6, 2026 |
| K252873 | k2m | Q Interbody Instruments | February 6, 2026 |
| K252087 | ulrich medical usa | Navigation Module of the Cortium® System | February 3, 2026 |
| K252755 | point robotics medtech | POINT Kinguide Agile Robotic Arm Surgical Stereotactic System | January 23, 2026 |
| K252962 | promethean restorative | DYNAMIS Navigation System | January 12, 2026 |
| K253661 | think surgical | TMINI Miniature Robotic System | December 22, 2025 |
| K252950 | proprio | Paradigm System | December 15, 2025 |
| K252841 | blue belt technologies | REAL INTELLIGENCE CORI XT (CORI XT) | December 5, 2025 |
| K251943 | spineology | Spineology Navigation Instruments | December 4, 2025 |
| K251314 | orthosoft inc. (d/b/a) zimmer cas | Rosa® Knee System | November 13, 2025 |
| K250599 | globus medical | ExcelsiusGPS Instruments | November 5, 2025 |
| K252088 | orthofix us | Firebird SI Navigation System | October 31, 2025 |