Midas REX Microsaws
Blade 185S65-05F-ARC MR SO 19X7X.5MM F A
3manufacturers in China registered for this device type
60catalogue 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) | K081475 |
| Record published | 2022-03-18 |
| Record revised | 2024-09-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 250S127-04 | In distribution | |
| 185S65-05F-ARC | In distribution | |
| 200S58-03-ARC | In distribution | |
| 345S165-05F | In distribution | |
| 330S95-04F | In distribution | |
| R390-04 | In distribution | |
| 300S70-06 | In distribution | |
| 110SB95-06F-BAY | In distribution | |
| 185S65-04F-ARC | In distribution | |
| 310S90-05F | In distribution | |
| 422R231-05 | In distribution | |
| 250S90-05 | In distribution | |
| 467R277-05 | In distribution | |
| 528R231-06-DP | In distribution | |
| 320S55-06 | In distribution | |
| 290S70-04F | In distribution | |
| 528R231-05-DP | In distribution | |
| R254-04 | In distribution | |
| 200S70-03F | In distribution | |
| 200S65-06-ARC | In distribution | |
| R250-04 | In distribution | |
| 561R345-05-BAY | In distribution | |
| 250S55-04 | In distribution | |
| 280S43-04F | In distribution | |
| 185S70-05F | In distribution | |
| 523R345-05 | In distribution | |
| 290S70-06F | In distribution | |
| 120S97-03F | In distribution | |
| 270S97-04 | In distribution | |
| 528R163-06F | In distribution | |
| R340-04F-PT | In distribution | |
| 170S70-06 | In distribution | |
| 160SB68-04F-BAY | In distribution | |
| 110S58-03 | In distribution | |
| 115S90-05F | In distribution | |
| 528R231-06 | In distribution | |
| 180S55-05 | In distribution | |
| 594R277-06 | In distribution | |
| 185S90-05F | In distribution | |
| 270S97-04F | In distribution | |
| 650R345-05 | In distribution | |
| 180S102-04F | In distribution | |
| 200S70-04F | In distribution | |
| 250S90-05F | In distribution | |
| R254-03 | In distribution | |
| 528R163-05F | In distribution | |
| ES200 | In distribution | |
| 150S70-04F | In distribution | |
| 180S102-03F | In distribution | |
| 270S97-04F-ARC | In distribution | |
| 185S90-04F | In distribution | |
| 295S70-05F | In distribution | |
| 345S170-05 | In distribution | |
| 455R150-05 | In distribution | |
| 120S97-04F | In distribution | |
| 115S55-05F | In distribution | |
| 625R231-05 | In distribution | |
| 250S90-04F | In distribution | |
| 528R69-06-TB | In distribution | |
| 200S65-04F-ARC | 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 |
| Mids REX MR8 | Medtronic Powered Surgical Solutions | 59 |
| 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 Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Xomed, Inc. | 510(k) number | 2021-12-15 | Class II | Under Investigation by firm | As a result of Medtronic’s integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between the set number of rota | 1447 units | 2023-06-09 |
| Medtronic Xomed, Inc. | 510(k) number | 2021-08-31 | Class II | Process control | There was an increase in complaints related to tip breaks and wobble/vibration. | 274,991 total devices | |
| Medtronic Powered Surgical Solutions | 510(k) number | 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.