Ion-L Navigated Instruments
510(k) K262121
Ion-L Navigated Instruments is a Class II device made by Surgentec LLC, cleared under FDA 510(k) K262121 on 24 Jul 2026, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK262121 | Date24 Jul 2026 | StatusActive |
Official records
- FDA 510(k) database K262121
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLO
- FDA applicant
- SurGenTec, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K262121
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ION-L Navigation Tray Assembly SR27-1002 | SR27-1002 | 00810131884994 | — | On the market |
Similar devices
Other devices filed under FDA product code OLO (Orthopedic Stereotaxic Instrument).
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- ORTHOMAP 3D 1.1 MODULE by Stryker Corp.
- iFuse Implant System - iFuse Navigation by Si-Bone Inc.
- DASH HIP by Brainlab AG
- Mako Total Knee Application by MAKO Surgical Corp.
- Stealth AXiS EM Emitter Arm Bed Kit SS 9736698 by Medtronic Navigation Inc.
- RIO 111613 by MAKO Surgical Corp.