Mids REX MR8
Tool MR8-10BA50DX MR8 10CM BAL Dxcrs 5MM
3manufacturers in China registered for this device type
59catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Medtronic Powered Surgical Solutions, United States |
|---|---|
| FDA product code | HBE |
| Device type | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4310 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K183515 |
| Record published | 2022-01-01 |
| Record revised | 2025-03-12 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MR8-10BA10 | In distribution | |
| MR8-10BA30DC | In distribution | |
| MR8-10BA60 | In distribution | |
| MR8-10BA50DF | In distribution | |
| MR8-10CY60 | In distribution | |
| MR8-10CY30BR | In distribution | |
| MR8-10BA40D | In distribution | |
| MR8-10TA23 | In distribution | |
| MR8-10BA50DX | In distribution | |
| MR8-10BA40T | In distribution | |
| MR8-10AC60 | In distribution | |
| MR8-10BA40DX | In distribution | |
| MR8-10BA20F | In distribution | |
| MR8-10BA40F | In distribution | |
| MR8-10BA60F | In distribution | |
| MR8-10OV40D | In distribution | |
| MR8-10MH22 | In distribution | |
| MR8-10BA40DC | In distribution | |
| MR8-10BA30T | In distribution | |
| MR8-10BA10D | In distribution | |
| MR8-10CY40 | In distribution | |
| MR8-10MH40 | In distribution | |
| MR8-10BA70DX | In distribution | |
| MR8-10MH22D | In distribution | |
| MR8-10CY60BR | In distribution | |
| MR8-10CY65DX | In distribution | |
| MR8-10AC60M | In distribution | |
| MR8-10AC50 | In distribution | |
| MR8-10BA30F | In distribution | |
| MR8-10BA30FL | In distribution | |
| MR8-10BA60DX | In distribution | |
| MR8-10BA30D | In distribution | |
| MR8-10CY50L | In distribution | |
| MR8-10BA10F | In distribution | |
| MR8-10BA50DC | In distribution | |
| MR8-10CY40BR | In distribution | |
| MR8-10BA50F | In distribution | |
| MR8-10MH17D | In distribution | |
| MR8-10BA20DF | In distribution | |
| MR8-10CY50BR | In distribution | |
| MR8-10MH30D | In distribution | |
| MR8-10MH30DC | In distribution | |
| MR8-10BA20D | In distribution | |
| MR8-10BA20 | In distribution | |
| MR8-10BA50FL | In distribution | |
| MR8-10OV40 | In distribution | |
| MR8-10BA20DFL | In distribution | |
| MR8-10BA60D | In distribution | |
| MR8-10MH17 | In distribution | |
| MR8-10BA50D | In distribution | |
| MR8-10BA30DFL | In distribution | |
| MR8-10BA60DF | In distribution | |
| MR8-10CY50 | In distribution | |
| MR8-10BA40DF | In distribution | |
| MR8-10BA10DFL | In distribution | |
| MR8-10BA30 | In distribution | |
| MR8-10CY40L | In distribution | |
| MR8-10BA15DF | In distribution | |
| MR8-10BA10DF | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Midas REX MR8 | Medtronic Powered Surgical Solutions | 1,006 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Stryker GmbH | 948 |
| Elan 4 | Aesculap AG | 529 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Synthes Gmbh | 514 |
| Zethon | Zethon Ltd | 237 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Stryker Leibinger Gmbh & Co. KG | 220 |
| Midas Rex® | Medtronic Powered Surgical Solutions | 167 |
| HiCUT Burs | Adeor Medical AG | 90 |
| Phasor | Phasor Health, LLC | 80 |
| Traumaone System | Biomet Microfixation | 62 |
| Midas REX Microsaws | Medtronic Powered Surgical Solutions | 60 |
| Midas Rex MR8 | Medtronic PS Medical | 59 |
Showing 12 of 269. All products under Drills, Burrs, Trephines & Accessories (Simple, Powered)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213454 | 2021-11-23 |
| K072315 | 2007-09-18 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-05-13 | Class II | Device Design | Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use. | 368 devices | 2017-06-13 |
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.