Zethon
BUR - 2.38MM, Fluted Cranio, 100MM X 2.3MM (75,000 RPM MAX)
3manufacturers in China registered for this device type
237catalogue numbers in this listing
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 | Zethon Ltd, United Kingdom |
|---|---|
| FDA product code | HBE |
| Device type | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4310 |
| Establishment | Manufacturer |
| 510(k) | K233958 |
| Record published | 2025-05-01 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C09-01535 | In distribution | |
| C07-02031S | In distribution | |
| C15-03051 | In distribution | |
| D09-03034 | In distribution | |
| C10-02031S | In distribution | |
| C07-02031 | In distribution | |
| C15-02254 | In distribution | |
| D09-05031 | In distribution | |
| C07-03051 | In distribution | |
| C07-06033 | In distribution | |
| C10-03034 | In distribution | |
| C10-03071 | In distribution | |
| C07-08061 | In distribution | |
| C07-07051 | In distribution | |
| C07-03031 | In distribution | |
| C07-02061 | In distribution | |
| C12-06061 | In distribution | |
| C15-05081 | In distribution | |
| C07-07061 | In distribution | |
| C18-02234S | In distribution | |
| C10-01249F | In distribution | |
| C10-04051 | In distribution | |
| C07-00531 | In distribution | |
| C10-04034S | In distribution | |
| C10-03034S | In distribution | |
| C07-06031 | In distribution | |
| C07-03561 | In distribution | |
| C07-01538L4 | In distribution | |
| C10-02149F | In distribution | |
| C10-01061 | In distribution | |
| C07-01038L6 | In distribution | |
| C10-01734S | In distribution | |
| D14-03054 | In distribution | |
| D09-06071 | In distribution | |
| C10-04032 | In distribution | |
| C07-06051 | In distribution | |
| C07-06031S | In distribution | |
| D09-07551 | In distribution | |
| C10-06032 | In distribution | |
| C07-07533 | In distribution | |
| C15-02234 | In distribution | |
| D14-04051 | In distribution | |
| C07-05061 | In distribution | |
| C12-06031S | In distribution | |
| C07-01538L6 | In distribution | |
| C12-04031 | In distribution | |
| D21-03034 | In distribution | |
| C07-03081 | In distribution | |
| C15-06081 | In distribution | |
| C15-05032 | In distribution | |
| C12-04061 | In distribution | |
| C10-04031 | In distribution | |
| C07-01038L4 | In distribution | |
| C10-06051 | In distribution | |
| D14-06033 | In distribution | |
| C18-02234 | In distribution | |
| C15-06051 | In distribution | |
| C07-01049F | In distribution | |
| C10-05081 | In distribution | |
| C07-03034 | In distribution | |
| C07-01538L8 | In distribution | |
| D26-03034 | In distribution | |
| D09-03051 | In distribution | |
| C10-03036 | In distribution | |
| C15-03061 | In distribution | |
| D09-03054 | In distribution | |
| C15-02031S | In distribution | |
| C15-06031S | In distribution | |
| D14-06051 | In distribution | |
| C15-01249F | In distribution | |
| C12-03031 | In distribution | |
| C07-05051 | In distribution | |
| C07-04061 | In distribution | |
| C10-02254 | In distribution | |
| C07-03061 | In distribution | |
| C15-02149F | In distribution | |
| C07-01734S | In distribution | |
| C10-03081 | In distribution | |
| C15-06032 | In distribution | |
| C07-05031 | In distribution | |
| C07-01531 | In distribution | |
| C12-05061 | In distribution | |
| C07-04031 | In distribution | |
| C10-02335 | In distribution | |
| C12-02031 | In distribution | |
| C12-06031 | In distribution | |
| C07-02551 | In distribution | |
| C12-05031S | In distribution | |
| C07-06061 | In distribution | |
| C07-01734 | In distribution | |
| D06-03047 | In distribution | |
| C07-01031 | In distribution | |
| C10-05061 | In distribution | |
| C10-03031 | In distribution | |
| C15-05033 | In distribution | |
| C15-01049F | In distribution | |
| D14-07551 | In distribution | |
| C18-03034 | In distribution | |
| C10-02061 | In distribution | |
| C07-02531 | In distribution | |
| C07-05033 | In distribution | |
| D09-04051 | In distribution | |
| C12-03061 | In distribution | |
| C10-01051 | In distribution | |
| C07-04051 | In distribution | |
| D14-04034 | In distribution | |
| C15-05051 | In distribution | |
| C10-05051 | In distribution | |
| D14-02551 | In distribution | |
| D14-06582 | In distribution | |
| C15-04051 | In distribution | |
| C07-07531 | In distribution | |
| C15-04061 | In distribution | |
| C10-01754 | In distribution | |
| D09-06033 | In distribution | |
| C07-01649F | In distribution | |
| C12-05031 | In distribution | |
| C15-05031S | In distribution | |
| C10-04031S | In distribution | |
| C10-04061 | In distribution | |
| C12-05051 | In distribution | |
| C10-04081 | In distribution | |
| C07-02561 | In distribution | |
| C10-02051 | In distribution | |
| C10-05036 | In distribution | |
| C07-05031S | In distribution | |
| D14-06031 | In distribution | |
| C10-06071 | In distribution | |
| C10-05031S | In distribution | |
| C15-07532 | In distribution | |
| C15-04031S | In distribution | |
| C10-01551 | In distribution | |
| C12-06051 | In distribution | |
| C15-07533 | In distribution | |
| C15-01649F | In distribution | |
| C10-06031 | In distribution | |
| C15-06582 | In distribution | |
| C15-03081 | In distribution | |
| C07-02531S | In distribution | |
| C07-02051 | In distribution | |
| D14-07533 | In distribution | |
| S101688 | In distribution | |
| C10-02234 | In distribution | |
| C10-05071 | In distribution | |
| S101461 | In distribution | |
| C15-03034S | In distribution | |
| C10-01649F | In distribution | |
| D14-03034 | In distribution | |
| C15-02234S | In distribution | |
| C07-03531 | In distribution | |
| C15-04031 | In distribution | |
| D12-03035 | In distribution | |
| C07-01051 | In distribution | |
| C07-01249F | In distribution | |
| C12-02234S | In distribution | |
| C15-05061 | In distribution | |
| D14-06071 | In distribution | |
| C07-03031S | In distribution | |
| C07-00851 | In distribution | |
| C10-01031 | In distribution | |
| C15-06071 | In distribution | |
| C15-02031 | In distribution | |
| C18-03061 | In distribution | |
| D09-06031 | In distribution | |
| C10-04071 | In distribution | |
| D14-03051 | In distribution | |
| C10-03061 | In distribution | |
| C10-05031 | In distribution | |
| C15-03054 | In distribution | |
| D26-06051 | In distribution | |
| C12-04031S | In distribution | |
| D14-03031 | In distribution | |
| C10-02031 | In distribution | |
| C10-02036 | In distribution | |
| C15-03034 | In distribution | |
| C12-03051 | In distribution | |
| C07-04081 | In distribution | |
| C15-06061 | In distribution | |
| C15-05031 | In distribution | |
| D14-05051 | In distribution | |
| C15-06031 | In distribution | |
| C18-03051 | In distribution | |
| C10-06036 | In distribution | |
| C10-04034 | In distribution | |
| C10-06081 | In distribution | |
| C07-08051 | In distribution | |
| C10-06033 | In distribution | |
| C15-03031 | In distribution | |
| D09-04034 | In distribution | |
| C10-03051 | In distribution | |
| D09-07533 | In distribution | |
| C10-04036 | In distribution | |
| S101691 | In distribution | |
| C07-02234S | In distribution | |
| C07-02149F | In distribution | |
| C10-05033 | In distribution | |
| C10-07533 | In distribution | |
| C10-02234S | In distribution | |
| D09-04031 | In distribution | |
| D09-05051 | In distribution | |
| C10-01734 | In distribution | |
| C18-03031S | In distribution | |
| C07-06081 | In distribution | |
| D09-06582 | In distribution | |
| C10-06031S | In distribution | |
| C07-01038L8 | In distribution | |
| D09-09033 | In distribution | |
| D09-03031 | In distribution | |
| C10-03031S | In distribution | |
| C07-01561 | In distribution | |
| C18-03031 | In distribution | |
| C12-04051 | In distribution | |
| C18-03034S | In distribution | |
| C12-02234 | In distribution | |
| C12-03034S | In distribution | |
| C15-02061 | In distribution | |
| C10-07532 | In distribution | |
| C10-01049F | In distribution | |
| C15-06033 | In distribution | |
| C07-05081 | In distribution | |
| C07-04031S | In distribution | |
| D14-05031 | In distribution | |
| C12-03034 | In distribution | |
| C07-02234 | In distribution | |
| C15-01734 | In distribution | |
| C10-06061 | In distribution | |
| C07-03034S | In distribution | |
| C07-01551 | In distribution | |
| C15-01734S | In distribution | |
| D06-01647 | In distribution | |
| C15-04081 | In distribution | |
| C10-03054 | In distribution | |
| D09-06051 | In distribution | |
| C10-05032 | In distribution | |
| C07-00551 | In distribution | |
| D14-04031 | In distribution | |
| C15-01754 | 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 |
| 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 |
| 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)
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.