Midas Rex®
Curvedbur CB11BA20D 11CMX2MM Ball Diamnd
3manufacturers in China registered for this device type
167catalogue 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) | K072315 |
| Record published | 2016-06-02 |
| Record revised | 2022-09-16 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment temperature -40 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| CB11BA20D | In distribution | ||
| CB09BA20 | In distribution | ||
| 180S102-04 | In distribution | ||
| CB11BA40D | In distribution | ||
| CB09BA20 | In distribution | ||
| ES210-R | In distribution | ||
| R340-06F | In distribution | ||
| 160SB90-06F-BAY | In distribution | ||
| 185S95-04F | In distribution | ||
| 345S165-05F | In distribution | ||
| 150S40-04F | In distribution | ||
| CB11BA30D | In distribution | ||
| CB09BA20D | In distribution | ||
| 180S55-04 | In distribution | ||
| 528R163-06F | In distribution | ||
| EA100 | In distribution | ||
| 185SB110-04-BAY | In distribution | ||
| 320S50-04 | In distribution | ||
| EF200 | In distribution | ||
| 115S90-04F | In distribution | ||
| 120S97-04F | In distribution | ||
| 185S90-04 | In distribution | ||
| R390-04 | In distribution | ||
| CB11BA20D | In distribution | ||
| 528R231-06 | In distribution | ||
| 270S97-04F-ARC | In distribution | ||
| ES310-R | In distribution | ||
| PA700 | 4 | In distribution | |
| 594R277-06 | In distribution | ||
| R250-03 | In distribution | ||
| 115S90-05F | In distribution | ||
| CB09BA30 | In distribution | ||
| 270S97-06F-ARC | In distribution | ||
| CB11BA40D | In distribution | ||
| 250S90-05F | In distribution | ||
| ES200-R | In distribution | ||
| 528R231-05-DP | In distribution | ||
| 280S43-04F | In distribution | ||
| 200S65-06-ARC | In distribution | ||
| R254-03 | In distribution | ||
| CB09BA40D | In distribution | ||
| ES300-R | In distribution | ||
| CB09BA30D | In distribution | ||
| EF200RF | In distribution | ||
| 528R231-06-DP | In distribution | ||
| CB11BA40 | In distribution | ||
| 411R231-06 | In distribution | ||
| 625R231-05 | In distribution | ||
| 115S55-04F | In distribution | ||
| 561R345-06-BAY | In distribution | ||
| CB11BA30D | In distribution | ||
| ES210 | In distribution | ||
| 300S70-06 | In distribution | ||
| 115S90-05F | In distribution | ||
| 180S55-04F | In distribution | ||
| 315S95-04F | In distribution | ||
| EA650 | In distribution | ||
| R254-03 | In distribution | ||
| 170S70-04F | In distribution | ||
| 345S130-05F | In distribution | ||
| EF201 | In distribution | ||
| ES300 | In distribution | ||
| R254-03F | In distribution | ||
| ES310 | In distribution | ||
| 110S58-03-ARC | In distribution | ||
| 80SB150-04F | In distribution | ||
| 333R150-06 | In distribution | ||
| CB09BA20D | In distribution | ||
| CB11BA30 | In distribution | ||
| ES200 | In distribution | ||
| ES210-R | In distribution | ||
| ES110 | In distribution | ||
| 185S65-04F-ARC | In distribution | ||
| 150S45-04F | In distribution | ||
| 170S70-06 | In distribution | ||
| R254-04 | In distribution | ||
| 150S40-03F | In distribution | ||
| 625R163-05F | In distribution | ||
| 523R345-06 | In distribution | ||
| CB09BA10D | In distribution | ||
| CB11BA20 | In distribution | ||
| 185S165-04F | In distribution | ||
| 150S70-05F | In distribution | ||
| CB09BA10 | In distribution | ||
| R340-04F-PT | In distribution | ||
| R254-04F | In distribution | ||
| 130SB68-04F | In distribution | ||
| 561R345-05-BAY | In distribution | ||
| 180S102-04F | In distribution | ||
| 110SB95-06F-BAY | In distribution | ||
| 345S120-05 | In distribution | ||
| CB11BA10 | In distribution | ||
| PC700-R | In distribution | ||
| CB11BA20 | In distribution | ||
| PA700 | 4 | In distribution | |
| CB09BA10D | In distribution | ||
| 115S55-04F | In distribution | ||
| ES100-R | In distribution | ||
| 250S90-04 | In distribution | ||
| 185S165-05F | In distribution | ||
| ES300-R | In distribution | ||
| R340-04F-PT | In distribution | ||
| RASP-CC-1 | In distribution | ||
| CB09BA40 | In distribution | ||
| PC700 | In distribution | ||
| 528R69-06-TB | In distribution | ||
| CB11BA10D | In distribution | ||
| CB09BA40D | In distribution | ||
| 528R231-05 | In distribution | ||
| 200S95-04F | In distribution | ||
| ES310-R | In distribution | ||
| 150S70-04F | In distribution | ||
| 115S55-05F | In distribution | ||
| ES210-R | In distribution | ||
| 422R231-05 | In distribution | ||
| 185S55-04F | In distribution | ||
| 115S90-04F | In distribution | ||
| RASP-ST-1 | In distribution | ||
| 455R277-05 | In distribution | ||
| 310S90-05F | In distribution | ||
| ES310-R | In distribution | ||
| PA700 | 4 | In distribution | |
| CB09BA30 | In distribution | ||
| 150S40-03F | In distribution | ||
| 333R150-05 | In distribution | ||
| CB11BA10 | In distribution | ||
| CB09BA10 | In distribution | ||
| 280S43-06F | In distribution | ||
| EA100-R | In distribution | ||
| ES110-R | In distribution | ||
| 460R277-06 | In distribution | ||
| ES300-R | In distribution | ||
| CB09BA30D | In distribution | ||
| ES110 | In distribution | ||
| ES310-R | In distribution | ||
| EF200RF | In distribution | ||
| 549R231-05 | In distribution | ||
| ES310-R | In distribution | ||
| R390-04 | In distribution | ||
| EA100 | In distribution | ||
| 330S95-04F | In distribution | ||
| 185S65-05F-ARC | In distribution | ||
| 360R146-03 | In distribution | ||
| ES300-R | In distribution | ||
| 310S90-04F | In distribution | ||
| RASP-CC-2 | In distribution | ||
| R390-06 | In distribution | ||
| CB11BA40 | In distribution | ||
| 650R345-05 | In distribution | ||
| EF200LO | In distribution | ||
| ES100 | In distribution | ||
| ES200 | In distribution | ||
| EF201RF | In distribution | ||
| CB11BA30 | In distribution | ||
| EF201RF | In distribution | ||
| 120S97-04F | In distribution | ||
| RASP-ST-2 | In distribution | ||
| 160SB68-04F-BAY | In distribution | ||
| 300S70-04 | In distribution | ||
| CB09BA40 | In distribution | ||
| 582R277-05 | In distribution | ||
| EF200 | In distribution | ||
| 200S70-04F | In distribution | ||
| 160SB90-06F-BAY | In distribution | ||
| CB11BA10D | In distribution | ||
| 180S55-05F | In distribution | ||
| EF201 | 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 |
| HiCUT Burs | Adeor Medical AG | 90 |
| Phasor | Phasor Health, LLC | 80 |
| Traumaone System | Biomet Microfixation | 62 |
| Midas REX Microsaws | Medtronic Powered Surgical Solutions | 60 |
| 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.