GALILEO Spine Alignment Monitoring System
FDA 510(k) K182524 · MiRus, LLC
510(k) numberK182524
Submission
- Device name
- GALILEO Spine Alignment Monitoring System
- Applicant
- MiRus, LLC
Marietta, GA, US - Received
- September 13, 2018
- Decision date
- June 17, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLO – Orthopedic Stereotaxic Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Specialty
- Neurology
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
Other 510(k)s with product code OLO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262506 | Remex Spine Surgery Navigation - Universal InstrumentsOLO · Special | Remex Medical Corp. | 08/20/2026SE |
| K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…OLO · Traditional | Suite 201, National Innovation Centre | 07/30/2026SE |
| K261205 | SPINEART Navigation Instrument SystemOLO · Traditional | Spineart SA | 07/29/2026SE |
| K262121 | Ion-L Navigated InstrumentsOLO · Special | SurGenTec, LLC | 07/24/2026SE |
| K261024 | TMINI Miniature Robotic SystemOLO · Traditional | THINK Surgical, Inc. | 07/24/2026SE |
| K261113 | Op.n Spine Navigation and Robotic GuidanceOLO · Traditional | Ecential Robotics | 07/22/2026SE |
| K261852 | OTS HipOLO · Special | Ortoma AB | 07/01/2026SE |
| K253921 | VERTICALE® Navigation InstrumentsOLO · Traditional | Silony Medical GmbH | 06/26/2026SE |
| K260480 | VELYS Robotic-Assisted SolutionOLO · Traditional | Depuy Ireland UC | 06/25/2026SE |
| K260369 | Dynamis Robotic Surgical SystemOLO · Traditional | LEM Surgical AG | 06/20/2026SE |
More from LEM Surgical AG
| 510(k) | Device | Decision |
|---|---|---|
| K253444 | EUROPA Posterior Cervical Fusion Navigated InstrumentsOLO · Traditional | 03/18/2026SE |
| K252733 | ATLAS Expandable Osteotomy Wedge SystemPLF · Traditional | 02/19/2026SE |
| K242516 | EUROPA Posterior Cervical Fusion SystemNKG · Traditional | 11/19/2024SE |
| K241175 | MiRus MoRe Lumbar Plating SystemKWQ · Traditional | 05/17/2024SE |
| K232348 | RIGEL 3DR Standalone Anterior Cervical Interbody Fusion SystemOVE · Traditional | 10/27/2023SE |
| K232481 | RIGEL 3DR Anterior Cervical Corpectomy SystemPLR · Traditional | 10/13/2023SE |
| K232154 | MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationOVD · Traditional | 09/11/2023SE |
| K230369 | EUROPA Navigated InstrumentsOLO · Traditional | 06/23/2023SE |
| K220441 | CYGNUS MoRe Anterior Cervical Plate SystemKWQ · Traditional | 09/16/2022SE |
| K220115 | ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemOVD · Traditional | 05/13/2022SE |
Questions and answers
When was GALILEO Spine Alignment Monitoring System cleared by the FDA?
GALILEO Spine Alignment Monitoring System (K182524) received a 510(k) decision of Substantially Equivalent on June 17, 2019, 277 days after the submission was received.
What is the product code of K182524?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.