RIWOtrack Navigation System
FDA 510(k) K230700 · Fiagon GmbH
510(k) numberK230700
Submission
- Device name
- RIWOtrack Navigation System
- Applicant
- Fiagon GmbH
Hennigsdorf, DE - Received
- March 13, 2023
- Decision date
- November 20, 2023
- 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 |
|---|---|---|
| K261540 | Cube 4D Navigation System, VirtuEye ProPGW · Special | 06/02/2026SE |
| K230065 | VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav…PNZ · Traditional | 05/26/2023SE |
| K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DPGW · Traditional | 07/19/2021SE |
| K201472 | VenSure Balloon Device, VenSure Nav Balloon DeviceLRC · Traditional | 08/26/2020SE |
| K200041 | FlexPointer 1.5 Single Use, FlexTube 3 Single UsePGW · Special | 03/10/2020SE |
| K163209 | Fiagon Navigation SystemHAW · Traditional | 09/14/2017SE |
| K163416 | Fiagon Navigation PointerTube Straight and PointerTube KeatPGW · Special | 02/16/2017SE |
| K162176 | Fiagon Navigation SystemPGW · Special | 12/01/2016SE |
| K161940 | Guidewire 0.6 Single UsePGW · Special | 09/18/2016SE |
| K151156 | Fiagon Navigation SystemHAW · Traditional | 04/01/2016SE |
Questions and answers
When was RIWOtrack Navigation System cleared by the FDA?
RIWOtrack Navigation System (K230700) received a 510(k) decision of Substantially Equivalent on November 20, 2023, 252 days after the submission was received.
What is the product code of K230700?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.