StealthStation S8 Spine Software
FDA 510(k) K251282 · Medtronic Navigation, Inc.
510(k) numberK251282
Submission
- Device name
- StealthStation S8 Spine Software
- Applicant
- Medtronic Navigation, Inc.
Lafayette, CO, US - Received
- April 24, 2025
- Decision date
- October 17, 2025
- 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 |
|---|---|---|
| K253379 | Stealth AXiS Cranial clinical applicationHAW · Traditional | 03/26/2026SE |
| K253395 | Stealth AXiS ENT clinical applicationPGW · Traditional | 03/16/2026SE |
| K253391 | Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator…ONO · Traditional | 03/13/2026SE |
| K253381 | Stealth AXiS Surgical System with Stealth AXiS Spine clinical applicationOLO · Traditional | 02/12/2026SE |
| K242464 | Stealth Spine Clamps; ModuLeX Shank MountsOLO · Traditional | 06/05/2025SE |
| K250307 | Visualase V2 MRI-guided Laser Ablation System (9736422)ONO · Traditional | 05/29/2025SE |
| K240465 | O-arm O2 Imaging SystemOWB · Traditional | 06/21/2024SE |
| K231976 | StealthStation Cranial Software, v3.1.5 (9735585)HAW · Traditional | 10/19/2023SE |
| K221087 | Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4HAW · Traditional | 06/10/2022SE |
| K211269 | Visualase MRI-Guided Laser Ablation System (SW 3.4)ONO · Traditional | 01/07/2022SE |
Questions and answers
When was StealthStation S8 Spine Software cleared by the FDA?
StealthStation S8 Spine Software (K251282) received a 510(k) decision of Substantially Equivalent on October 17, 2025, 176 days after the submission was received.
What is the product code of K251282?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.