CORUS Navigation System-GN
FDA 510(k) K261665 · Providence Medical Technology, Inc.
510(k) numberK261665
Submission
- Device name
- CORUS Navigation System-GN
- Applicant
- Providence Medical Technology, Inc.
Pleasanton, CA, US - Received
- May 20, 2026
- Decision date
- June 18, 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 |
|---|---|---|---|
| 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 |
|---|---|---|
| K253676 | CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D)MRW · Traditional | 05/14/2026SE |
| K253190 | CORUS-LX ImplantMRW · Traditional | 11/20/2025SE |
| K251060 | CORUS Navigation System-GXOLO · Traditional | 07/30/2025SE |
| K251885 | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantMRW · Special | 07/10/2025SE |
| K241035 | PMT Posterior Cervical Stabilization System (PCSS)MRW · Traditional | 06/25/2024SE |
| K240625 | CORUS Navigation Access SystemOLO · Traditional | 05/03/2024SE |
| K230840 | PMT Facet Fixation System, Lumbar (PMT FFS-LX)MRW · Traditional | 12/19/2023SE |
| K230297 | PMT Expandable Cage (PMT EXP)MRW · Traditional | 08/11/2023SE |
| K220951 | PMT Facet Fixation System (PMT FFS)MRW · Traditional | 12/09/2022SE |
| K212636 | CORUS Spinal System-XHRX · Traditional | 10/15/2021SE |
Questions and answers
When was CORUS Navigation System-GN cleared by the FDA?
CORUS Navigation System-GN (K261665) received a 510(k) decision of Substantially Equivalent on June 18, 2026, 29 days after the submission was received.
What is the product code of K261665?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.