Stealth-Midas System
by Medtronic Powered Surgical Solutions
510(k) K160713
Stealth-Midas System is a Class II device made by Medtronic Powered Surgical Solutions, cleared under FDA 510(k) K160713 on 26 May 2016, 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 | NumberK160713 | Date26 May 2016 | StatusActive |
Official records
- FDA 510(k) database K160713
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- Withdrawn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 K160713
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 | |||
|---|---|---|---|---|
| Midas Rex EM200N-R | EM200N-R | 00763000172855 | — | On the market |
| MIDAS REX MR7 PM700 | PM700 | 00763000430986 | — | On the market |
| MIDAS REX PA600 | PA600 | 00763000080082 | — | On the market |
| Midas Rex PA600 | PA600 | 00763000337537 | — | On the market |
| Midas Rex PA600N | PA600N | 00763000337544 | — | On the market |
| MIDAS REX PA600N | PA600N | 00763000086978 | — | On the market |
| Midas Rex PM700 | PM700 | 00763000096779 | — | On the market |
| Midas Rex PM700N | PM700N | 00763000172824 | — | On the market |
| Midas Rex PM700N-R | PM700N-R | 00763000172831 | — | On the market |
| MIDAS REX STEALTH MIDAS EM200N | EM200N | 00763000430900 | — | On the market |
| MIDAS REX STEALTH-MIDAS PM700N | PM700N | 00763000430993 | — | On the market |
| Stealth Midas EM200N-R | EM200N-R | 00643169595194 | — | On the market |
| Stealth Midas™ EM200N | EM200N | 00763000172848 | — | On the market |
| Stealth Midas™ EM200N | EM200N | 00643169595163 | — | On the market |
| Stealth Midas™ PA600N | PA600N | 00643169595187 | — | On the market |
| Stealth Midas™ PM700N | PM700N | 00643169595170 | — | On the market |
Similar devices
Other devices filed under FDA product code OLO (Orthopedic Stereotaxic Instrument).
- Stealth AXiS EM Emitter Arm Bed Kit SS 9736698 by Medtronic Navigation Inc.
- RIO 111613 by MAKO Surgical Corp.
- OMNIBotics NS-5016L by OMNIlife science, Inc.
- REAL INTELLIGENCE™ CORI™ by Blue Belt Technologies, Inc.
- Mako Total Hip Application, Mako Total Knee Application by MAKO Surgical Corp.
- OMNIBotics NV-CRD05 by OMNIlife science, Inc.
- Medtronic 9735283 by Medtronic Navigation Inc.
- Mazor X Spine Disposable Kit KIT0574-12 by MAZOR ROBOTICS LTD
- GX Navigation Instrument System by Life Spine, Inc.
- ROSA Partial Knee System by Orthosoft Inc. (d/b/a) Zimmer CAS