Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II
FDA 510(k) K251315 · Remex Medical Corp.
510(k) numberK251315
Submission
- Device name
- Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II
- Applicant
- Remex Medical Corp.
Taichung, TW - Received
- April 29, 2025
- Decision date
- May 29, 2025
- 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 |
|---|---|---|
| K262506 | Remex Spine Surgery Navigation - Universal InstrumentsOLO · Special | 08/20/2026SE |
| K243560 | Remex Spine Surgery Navigation InstrumentOLO · Special | 12/13/2024SE |
| K241625 | Anatase Navi Disposable InstrumentOLO · Special | 07/05/2024SE |
| K233513 | Remex Spine Surgery Navigation System IIOLO · Special | 05/01/2024SE |
| K230783 | Anatase Spine Surgery Navigation SystemOLO · Special | 04/21/2023SE |
| K220348 | Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-VOLO · Traditional | 07/14/2022SE |
Questions and answers
When was Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II cleared by the FDA?
Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II (K251315) received a 510(k) decision of Substantially Equivalent on May 29, 2025, 30 days after the submission was received.
What is the product code of K251315?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.