Midas REX Stealth-Midas MR8
The Stealth-Midas MR8 pneumatic navigated handpiece powers compatible tools for drilling, burring and removing bone or hard tissue in cranial and spinal surgery. An optical tracker enables…
The Stealth-Midas MR8 pneumatic navigated handpiece powers compatible tools for drilling, burring and removing bone or hard tissue in cranial and spinal surgery. An optical tracker enables its use with the StealthStation S8 navigation system.
The tracker lets the system locate selected dissecting tools relative to registered anatomy. Navigation uses CT or MR models, fluoroscopic images or digitized landmarks where a rigid anatomical reference can be identified.
Listed Item
Motor PM800N MR8 Pneumatic Navigated S8
Reusable Handpiece
The navigated handpiece and associated attachments are reusable and supplied nonsterile. Compatible dissecting tools and MR8 ClearView burs are separate sterile, single use components. The handpiece provides powered tool operation, while the external navigation platform assists positioning.
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Medtronic Powered Surgical Solutions, United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K183644 |
| Record published | 2021-12-05 |
| Record revised | 2024-05-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PM800N | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Valence Robotic Navigation System | Alphatec Spine, Inc. | 813 |
| Olympic | Astura Medical | 684 |
| Excelsius GPS | Globus Medical, Inc. | 383 |
| Orthopedic Stereotaxic Instrument | Medtronic Navigation, Inc. | 356 |
| Masada | Astura Medical | 335 |
| Excelsiusgps | Globus Medical, Inc. | 297 |
| Invictus | Alphatec Spine, Inc. | 235 |
| OrthAlign Plus | OrthAlign, Inc. | 210 |
| Arvis ® | Kico Knee Innovation Company | 174 |
| OMNIBotics | Omni Life Science, Inc. | 150 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 137 |
| Navigation Instruments | VB Spine LLC | 135 |
Showing 12 of 1,127. All products under Orthopedic Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K183644 | 2019-05-22 |
| K160713 | 2016-05-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.