HiCUT Burs
90 catalogue numbers from 1.5 mm diamond ball standard, listed by Adeor Medical AG, Germany, under Drills, Burrs, Trephines & Accessories (Simple, Powered). 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
90catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Adeor Medical AG, Germany |
|---|---|
| FDA product code | HBE |
| Device type | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4310 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K130755 |
| Record published | 2021-06-10 |
| Record revised | 2023-05-26 (version 2) |
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, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.5 mm diamond ball standard | In distribution | |
| 3.0 mm neuro Matchstick Diamond | In distribution | |
| 1.8 mm neuro Matchstick | In distribution | |
| 3.0 mm diamond ball standard | In distribution | |
| 2.0 mm neuro Matchstick Diamond | In distribution | |
| 4.0 mm oval | In distribution | |
| 5.0 mm diamond ball standard | In distribution | |
| 2.5 mm neuro Matchstick | In distribution | |
| 4.8 mm balltip | In distribution | |
| 3.0 mm balltip | In distribution | |
| Craniotome Cutter, spiral blade, large | In distribution | |
| Craniotome Cutter, large | In distribution | |
| 2.2 mm neuro diamond Matchstick | In distribution | |
| Lindemann 1.65 x 20 mm | In distribution | |
| 2.0 mm drill | In distribution | |
| 1.0 mm diamond ball standard | In distribution | |
| 2.0 mm balltip | In distribution | |
| 1.8 mm neuro diamond Matchstick | In distribution | |
| 2.5 mm neuro Matchstick Diamond | In distribution | |
| 2.5 mm neuro Matchstick | In distribution | |
| 8.0 mm diamond ball standard | In distribution | |
| Craniotome cutter, small | In distribution | |
| 6.0 mm balltip, smooth cut | In distribution | |
| 3.0 mm neuro Matchstick | In distribution | |
| 3.0 mm diamond ball standard | In distribution | |
| 6.4 mm acorn | In distribution | |
| 4.2 mm diamond ball coarse | In distribution | |
| 2.0 mm balltip | In distribution | |
| 4.8 mm balltip TC | In distribution | |
| 1.0 mm diamond ball coarse | In distribution | |
| 2.0 mm diamond ball standard | In distribution | |
| 1.5 mm balltip | In distribution | |
| 5.5 mm oval | In distribution | |
| Craniotome cutter, straight blade, medium | In distribution | |
| 6.4 mm balltip TC | In distribution | |
| 3.2 mm balltip, smooth cut | In distribution | |
| 1.0 mm neuro Matchstick | In distribution | |
| 25.4 mm diamond disc | In distribution | |
| 4.0 mm balltip | In distribution | |
| 2.0 mm neuro Matchstick | In distribution | |
| 3.0 mm drill | In distribution | |
| 1.5 mm neuro Matchstick | In distribution | |
| 4.5 mm neuro Matchstick Diamond | In distribution | |
| 3.0 mm neuro Matchstick Diamond | In distribution | |
| 3.2 mm balltip | In distribution | |
| 3.5 mm neuro Matchstick Diamond | In distribution | |
| 2.1 mm diamond ball coarse | In distribution | |
| 1.0 mm balltip | In distribution | |
| 3.3 mm diamond ball standard | In distribution | |
| 6.0 mm diamond ball standard | In distribution | |
| 2.5 mm neuro Matchstick | In distribution | |
| 4.2 mm diamond ball standard | In distribution | |
| 2.2 mm neuro Matchstick, MR conditional | In distribution | |
| 1.5 mm drill | In distribution | |
| 2.1 mm diamond ball standard | In distribution | |
| 3.0 mm neuro Matchstick Diamond | In distribution | |
| 2.2 mm neuro Matchstick | In distribution | |
| 5.0 mm diamond ball coarse | In distribution | |
| 0.8 mm diamond ball standard | In distribution | |
| Lindemann 1.65 x 10 mm | In distribution | |
| 3.3 mm diamond ball coarse | In distribution | |
| 3.0 mm neuro Matchstick Diamond | In distribution | |
| 3.5 mm neuro Matchstick Diamond | In distribution | |
| Metal cutter, 3.0 mm | In distribution | |
| 6.5 mm barrel | In distribution | |
| 2.5 mm neuro Matchstick | In distribution | |
| 2.0 mm neuro Matchstick | In distribution | |
| 2.5 mm neuro Matchstick Diamond | In distribution | |
| 1.0 mm neuro diamond Matchstick | In distribution | |
| 3.4 mm drill, MR conditional | In distribution | |
| 1.5 mm diamond ball coarse | In distribution | |
| Craniotome Cutter, spiral blade, medium | In distribution | |
| 4.0 mm balltip, smooth cut | In distribution | |
| Craniotome Cutter, spiral blade, small | In distribution | |
| 4.0 mm balltip | In distribution | |
| 6.0 mm diamond ball coarse | In distribution | |
| 4.2 mm diamond ball extra coarse | In distribution | |
| 4.5 mm neuro Matchstick Diamond | In distribution | |
| 4.5 mm drill, MR conditional | In distribution | |
| 7.5 mm balltip | In distribution | |
| 0.8 mm diamond ball coarse | In distribution | |
| 5.0 mm balltip, smooth cut | In distribution | |
| 1.0 mm pin | In distribution | |
| 3.0 mm neuro diamond Matchstick | In distribution | |
| 1.5 mm neuro Matchstick | In distribution | |
| 6.4 mm balltip | In distribution | |
| 4.8 mm balltip, MR conditional | In distribution | |
| 4.0 mm diamond ball standard | In distribution | |
| 2.0 mm balltip | In distribution | |
| 1.0 mm pin -30% blade length | 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 |
| 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 |
|---|---|
| K191479 | 2021-04-11 |
| K130755 | 2014-06-27 |
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.