OLO — Orthopedic Stereotaxic Instrument Class II
FDA product code OLO covers "Orthopedic Stereotaxic Instrument", a Class II medical device regulated under 21 CFR 882.4560. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261852 | ortoma | OTS Hip | July 1, 2026 |
| K253921 | silony medical | VERTICALE® Navigation Instruments | June 26, 2026 |
| K260480 | depuy ireland uc | VELYS Robotic-Assisted Solution | June 25, 2026 |
| K260369 | lem surgical | Dynamis Robotic Surgical System | June 20, 2026 |
| K261665 | providence medical technology | CORUS Navigation System-GN | June 18, 2026 |
| K260571 | life spine | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | June 2, 2026 |
| K261060 | tyber medical | Navigated LLIF Impactable Tracker | May 29, 2026 |
| K254157 | medos international sarl | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | May 26, 2026 |
| K260329 | surgentec | Ion-C Navigation Instruments | May 22, 2026 |
| K260582 | orthosoft inc. (d/b/a) zimmer cas | ROSA® Shoulder System | May 21, 2026 |
| K252880 | pytheas navigation | Pytheas Your Guided Trajectory | May 11, 2026 |
| K260011 | foundation surgical group | Foundation Surgical Navigated Lateral Disc Prep Instruments | April 16, 2026 |
| K254158 | spineart | SPINEART Navigation Instrument System | April 9, 2026 |
| K260240 | medos international sarl | SYMPHONY Navigation Ready Instruments | March 27, 2026 |
| K260601 | blue belt technologies | REAL INTELLIGENCE CORI | March 26, 2026 |
| K252037 | curexo | CUVIS-joint (CJ150) | March 25, 2026 |
| K253604 | surgentec | TiLink-L Navigation Instruments | March 20, 2026 |
| K253444 | mirus | EUROPA Posterior Cervical Fusion Navigated Instruments | March 18, 2026 |
| K260546 | k2m | Q Pedicle Instruments | March 17, 2026 |
| K260010 | think surgical | TMINI® Miniature Robotic System | March 3, 2026 |