Navigation Module of the Cortium® System
FDA 510(k) K252087 · Ulrich Medical USA, Inc.
510(k) numberK252087
Submission
- Device name
- Navigation Module of the Cortium® System
- Applicant
- Ulrich Medical USA, Inc.
Plano, TX, US - Received
- July 2, 2025
- Decision date
- February 3, 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 |
|---|---|---|
| K251719 | Momentum® Posterior Spinal Fixation SystemNKB · Special | 07/01/2025SE |
| K241396 | uCerv Flux-C 3D Porous Titanium Cervical InterbodyODP · Special | 05/23/2024SE |
| K240515 | uNion® MAX Cervical Plate SystemKWQ · Special | 03/18/2024SE |
| K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…PML · Traditional | 10/20/2023SE |
| K230614 | CortiumNKG · Traditional | 05/02/2023SE |
| K223274 | Momentum® MIS Posterior Spinal Fixation SystemNKB · Special | 11/28/2022SE |
| K220696 | uCerv Flux-C 3D Porous Titanium Cervical InterbodyODP · Traditional | 08/19/2022SE |
| K200845 | Navigation Module of the Momentum SystemOLO · Traditional | 09/10/2020SE |
| K191932 | Momentum Posterior Spinal Fixation SystemNKB · Traditional | 10/02/2019SE |
| K181921 | Solidity Vertebral Body ReplacementMQP · Traditional | 11/16/2018SE |
Questions and answers
When was Navigation Module of the Cortium® System cleared by the FDA?
Navigation Module of the Cortium® System (K252087) received a 510(k) decision of Substantially Equivalent on February 3, 2026, 216 days after the submission was received.
What is the product code of K252087?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.