SYMPHONY Navigation Ready Instruments
FDA 510(k) K260240 · Medos International SARL
510(k) numberK260240
Submission
- Device name
- SYMPHONY Navigation Ready Instruments
- Applicant
- Medos International SARL
Le Locle, CH - Received
- January 26, 2026
- Decision date
- March 27, 2026
- 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 |
|---|---|---|
| K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyOLO · Traditional | 05/26/2026SE |
| K253249 | TriALTIS Spine SystemNKB · Special | 10/21/2025SE |
| K243249 | TriALTIS Spine SystemNKB · Traditional | 01/17/2025SE |
| K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysOLO · Traditional | 09/16/2024SE |
| K242042 | TriALTIS Spine SystemNKB · Traditional | 09/09/2024SE |
| K233684 | TriALTIS Spine SystemNKB · Special | 12/12/2023SE |
| K233366 | SYMPHONY OCT SystemNKG · Special | 11/09/2023SE |
| K232492 | 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite…MBI · Traditional | 10/06/2023SE |
| K231479 | TriALTIS Spine SystemNKB · Traditional | 09/22/2023SE |
| K223438 | TELIGEN System Peripheral Motor Nerve Stimulation IndicationsPDQ · Traditional | 02/10/2023SE |
Questions and answers
When was SYMPHONY Navigation Ready Instruments cleared by the FDA?
SYMPHONY Navigation Ready Instruments (K260240) received a 510(k) decision of Substantially Equivalent on March 27, 2026, 60 days after the submission was received.
What is the product code of K260240?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.