Remex Spine Surgery Navigation - Universal Instruments
FDA 510(k) K262506 · Remex Medical Corp.
510(k) numberK262506
Submission
- Device name
- Remex Spine Surgery Navigation - Universal Instruments
- Applicant
- Remex Medical Corp.
Taichung, TW - Received
- July 21, 2026
- Decision date
- August 20, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|---|
| 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 |
| K261665 | CORUS Navigation System-GNOLO · Special | Providence Medical Technology, Inc. | 06/18/2026SE |
More from Providence Medical Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251315 | Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System IIOLO · Special | 05/29/2025SE |
| K243560 | Remex Spine Surgery Navigation InstrumentOLO · Special | 12/13/2024SE |
| K241625 | Anatase Navi Disposable InstrumentOLO · Special | 07/05/2024SE |
| K233513 | Remex Spine Surgery Navigation System IIOLO · Special | 05/01/2024SE |
| K230783 | Anatase Spine Surgery Navigation SystemOLO · Special | 04/21/2023SE |
| K220348 | Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-VOLO · Traditional | 07/14/2022SE |
Questions and answers
When was Remex Spine Surgery Navigation - Universal Instruments cleared by the FDA?
Remex Spine Surgery Navigation - Universal Instruments (K262506) received a 510(k) decision of Substantially Equivalent on August 20, 2026, 30 days after the submission was received.
What is the product code of K262506?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.