Op.n(TM) Navigation
510(k) K242914
Op.n(TM) Navigation is a Class II device made by Ecential Robotics, cleared under FDA 510(k) K242914 on 7 Mar 2025, 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 | NumberK242914 | Date7 Mar 2025 | StatusActive |
Official records
- FDA 510(k) database K242914
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLO
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K242914
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 | |||
|---|---|---|---|---|
| Navigation Instrument tray A00067 | A00067 | 03701311500902 | — | On the market |
| Op.n Camera I00026 | I00026 | 03701311501275 | — | On the market |
| Op.n ChoiceSpine App L60018 | L60018 | 03701311501497 | — | On the market |
| Op.n Core ethernet cable I01016 | I01016 | 03701311501459 | — | On the market |
| Op.n Core HDMI cable I01018 | I01018 | 03701311501466 | — | On the market |
| Op.n Core I01014 | I01014 | 03701311501435 | — | On the market |
| Op.n Core Power Cord I01015 | I01015 | 03701311501442 | — | On the market |
| Op.n Perla TL Nav Software L60017 | L60017 | 03701311501480 | — | On the market |
| Op.n Tracker A A00063 | A00063 | 03701311500865 | — | On the market |
| Op.n Tracker B A00064 | A00064 | 03701311500872 | — | On the market |
| Op.n Tracker C A00065 | A00065 | 03701311500889 | — | On the market |
| Op.n Tracker D A00066 | A00066 | 03701311500896 | — | On the market |
| Tracker fixation screw A00075 | A00075 | 03701311501282 | — | On the market |
Similar devices
Other devices filed under FDA product code OLO (Orthopedic Stereotaxic Instrument).
- ARVIS ® IN-18500 by KICO KNEE INNOVATION COMPANY PTY LIMITED
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- OMNIBotics NS-5015R by OMNIlife science, Inc.
- Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II by Remex Medical Corp.
- iASSIST Knee System by Orthosoft Inc. (d/b/a) Zimmer CAS
- 6003-300-041 by Stryker Leibinger
- Navigated INFINITY™ Occipitocervical Upper Thoracic System NAVG3606010 by MEDTRONIC SOFAMOR DANEK, INC.
- mBôs (Monogram mBôs TKA System) by Monogram Orthopaedics, Inc.
- OMNIBotics NS-5036A by OMNIlife science, Inc.
- Medtronic 9735500 by Medtronic Navigation Inc.