Ion-C Navigation Instruments
FDA 510(k) K260329 · SurGenTec, LLC
510(k) numberK260329
Submission
- Device name
- Ion-C Navigation Instruments
- Applicant
- SurGenTec, LLC
Boca Raton, FL, US - Received
- January 30, 2026
- Decision date
- May 22, 2026
- 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 |
|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®)FMF · Special | 08/26/2026SE |
| K261381 | TiLink-L SI Joint Fusion SystemOUR · Traditional | 08/24/2026SE |
| K262121 | Ion-L Navigated InstrumentsOLO · Special | 07/24/2026SE |
| K261209 | Ion-LMRW · Traditional | 06/11/2026SE |
| K253604 | TiLink-L Navigation InstrumentsOLO · Traditional | 03/20/2026SE |
| K251714 | Ion-CMRW · Traditional | 01/16/2026SE |
| K251720 | OsteoFlo HydroFiberMQV · Special | 07/02/2025SE |
| K243949 | OsteoFlo HydroFiberMQV · Traditional | 05/28/2025SE |
| K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)KNW · Traditional | 04/24/2025SE |
| K243580 | GraftGun Universal Graft Delivery System (GDS)FMF · Traditional | 02/05/2025SE |
Questions and answers
When was Ion-C Navigation Instruments cleared by the FDA?
Ion-C Navigation Instruments (K260329) received a 510(k) decision of Substantially Equivalent on May 22, 2026, 112 days after the submission was received.
What is the product code of K260329?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.