Mazor X System / Mazor X Stealth Edition
FDA 510(k) K251316 · Mazor Robotics , Ltd.
510(k) numberK251316
Submission
- Device name
- Mazor X System / Mazor X Stealth Edition
- Applicant
- Mazor Robotics , Ltd.
Caeasarea, IL - Received
- April 29, 2025
- Decision date
- September 11, 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 |
|---|---|---|
| K230064 | Mazor X System (Mazor X Stealth Edition)OLO · Traditional | 04/07/2023SE |
| K203005 | Mazor XOLO · Special | 10/27/2020SE |
| K200935 | Mazor XOLO · Special | 05/08/2020SE |
| K182077 | Mazor X System (Mazor X Stealth Edition)OLO · Traditional | 11/02/2018SE |
| K180307 | Mazor XOLO · Special | 04/30/2018SE |
| K172522 | Mazor XOLO · Special | 09/15/2017SE |
| K163221 | Mazor XOLO · Traditional | 04/04/2017SE |
| K152041 | Renaissance X SystemOLO · Special | 11/17/2015SE |
| K140167 | Renaissance X SystemOLO · Traditional | 09/10/2014SE |
| K120812 | RenaissanceHAW · Traditional | 07/12/2012SE |
Questions and answers
When was Mazor X System / Mazor X Stealth Edition cleared by the FDA?
Mazor X System / Mazor X Stealth Edition (K251316) received a 510(k) decision of Substantially Equivalent on September 11, 2025, 135 days after the submission was received.
What is the product code of K251316?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.