Spineology Navigation Instruments
FDA 510(k) K180796 · Spineology, Inc.
510(k) numberK180796
Submission
- Device name
- Spineology Navigation Instruments
- Applicant
- Spineology, Inc.
Saint Paul, MN, US - Received
- March 27, 2018
- Decision date
- May 2, 2018
- 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 |
|---|---|---|
| K251302 | OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB · Traditional | 12/15/2025SE |
| K251943 | Spineology Navigation InstrumentsOLO · Special | 12/04/2025SE |
| K230927 | OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB · Traditional | 11/01/2023SE |
| K231781 | OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB · Special | 10/18/2023SE |
| K213876 | Spineology Navigation InstrumentsOLO · Traditional | 08/05/2022SE |
| K210155 | Duo Expandable Interbody Fusion SystemMAX · Special | 02/19/2021SE |
| K192047 | Rampart One Lumbar Interbody Fusion SystemOVD · Special | 08/23/2019SE |
| K191091 | Rampart One Lumbar Interbody Fusion SystemOVD · Special | 05/23/2019SE |
| K190055 | Duo Lumbar Interbody Fusion DeviceMAX · Special | 03/07/2019SE |
| K182322 | Duo Lumbar Interbody Fusion DeviceMAX · Traditional | 10/24/2018SE |
Questions and answers
When was Spineology Navigation Instruments cleared by the FDA?
Spineology Navigation Instruments (K180796) received a 510(k) decision of Substantially Equivalent on May 2, 2018, 36 days after the submission was received.
What is the product code of K180796?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.