Ion-C Navigation Instruments
510(k) K260329
Ion-C Navigation Instruments is a Class II device made by Surgentec LLC, cleared under FDA 510(k) K260329 on 22 May 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 | NumberK260329 | Date22 May 2026 | StatusActive |
Official records
- FDA 510(k) database K260329
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- Withdrawn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 K260329
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 Navigation Drill Bit - 4.5mm SR12-6509 | SR12-6509 | 00810131882464 | — | On the market |
| Ion Navigation Drill Bit - 5.0mm SR12-6510 | SR12-6510 | 00810131882440 | — | On the market |
| Ion Navigation Drill Bit - 5.5mm SR12-6511 | SR12-6511 | 00810131882457 | — | On the market |
| Ion Navigation Inserter AO SR12-6501 | SR12-6501 | 00810131883669 | — | On the market |
| ION-C Navigation Drill Guide - Adjustable SR12-2700 | SR12-2700 | 00810131883270 | — | On the market |
| ION-C Navigation Locator SR12-2512 | SR12-2512 | 00810131882433 | — | On the market |
| ION-C Navigation Reusable Tray Assembly SR25-1002 | SR25-1002 | 00810131884970 | — | On the market |
| ION-C Navigation Reusable Tray SR25-7005 | SR25-7005 | 00810131884871 | — | On the market |
Similar devices
Other devices filed under FDA product code OLO (Orthopedic Stereotaxic Instrument).
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- IMNS MEDACTA NAVIGATION SYSTEM by Medacta International S.A.
- OMNIBotics KS-S1002 by OMNIlife science, Inc.
- NavLock™ 9734834 by Medtronic Navigation Inc.
- 9734555 by Medtronic Navigation Inc.
- VELYS Robotic-Assisted Solution by DePuy Ireland UC
- VADER Pedicle System, Dilator Navigated, Ø 18.5 mm 42-648N by icotec AG