Spine Navigation and Robotic-Assistance Device
FDA 510(k) K233228 · Ecential Robotics
510(k) numberK233228
Submission
- Device name
- Spine Navigation and Robotic-Assistance Device
- Applicant
- Ecential Robotics
Gieres, FR - Received
- September 28, 2023
- Decision date
- June 14, 2024
- 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 |
|---|---|---|
| K261113 | Op.n Spine Navigation and Robotic GuidanceOLO · Traditional | 07/22/2026SE |
| K242914 | Op.n(TM) NavigationOLO · Traditional | 03/07/2025SE |
| K231886 | SURGIVISIO DeviceOLO · Special | 07/27/2023SE |
| K221028 | SURGIVISIO DeviceOLO · Traditional | 07/06/2022SE |
| K220946 | SURGIVISIO DeviceOWB · Special | 04/15/2022SE |
| K220627 | SURGIVISIO DeviceOWB · Special | 03/18/2022SE |
Questions and answers
When was Spine Navigation and Robotic-Assistance Device cleared by the FDA?
Spine Navigation and Robotic-Assistance Device (K233228) received a 510(k) decision of Substantially Equivalent on June 14, 2024, 260 days after the submission was received.
What is the product code of K233228?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.