Invictus Robotic Navigation Instruments
510(k) K240951
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Overview
This robotic navigation system is designed for spine surgeons to achieve precise and minimally invasive procedures.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK240951 | Date6 Jun 2024 | StatusActive |
Official records
- FDA 510(k) database K240951
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- Withdrawn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 K240951
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 | |||
|---|---|---|---|---|
| Invictus 17484-RN | 17484-RN | 00190376556116 | — | On the market |
| Invictus 17485-RN | 17485-RN | 00190376556123 | — | On the market |
| Invictus 17486-RN | 17486-RN | 00190376556130 | — | On the market |
| Invictus 17487-RN | 17487-RN | 00190376556147 | — | On the market |
| Invictus 17488-RN | 17488-RN | 00190376601533 | — | On the market |
| Invictus 17489-RN | 17489-RN | 00190376601540 | — | On the market |
| Invictus 17490-RN | 17490-RN | 00190376601557 | — | On the market |
| Invictus 17491-RN | 17491-RN | 00190376601564 | — | On the market |
Similar devices
Other devices filed under FDA product code OLO (Orthopedic Stereotaxic Instrument).
- Practical Navigation Surgical Guidance System (PNSGS) by Practical Navigation, LLC
- Navigated INFINITY™ Instruments by MEDTRONIC SOFAMOR DANEK, INC.
- REAL INTELLIGENCE CORI by Blue Belt Technologies, Inc.
- Mako 700000625059 by MAKO Surgical Corp.
- Spine Wave Navigated Instruments by Spine Wave, Inc.
- 9734738 by Medtronic Navigation Inc.
- REAL INTELLIGENCE™ CORI™ XT (CORI XT) by Blue Belt Technologies, Inc.
- DASH KNEE by Brainlab AG
- S-COMP Reform® POCT Navigation Instruments by Precision Spine, Inc.
- OMNIBotics NS-40400 by OMNIlife science, Inc.