Drills, Burrs, Trephines & Accessories (Simple, Powered)
Drill F.10-20MM Screws,sagi.split,stryk.
3manufacturers in China registered for this device type
220catalogue 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 | Stryker Leibinger Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | HBE |
| Device type | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4310 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K070876 |
| Record published | 2016-08-24 |
| Record revised | 2026-07-28 (version 8) |
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 |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 3 to 150 mm |
| Distribution end date | 2025-03-03 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60-19996 | Length 17.0 mm | In distribution |
| 60-16535 | Length 26.0 mm | In distribution |
| 91-19526 | Length 26.0 mm | In distribution |
| 60-95420 | Diameter: 1.95 Millimeter | In distribution |
| 60-16908 | Length 9.0 mm | In distribution |
| 60-16820 | Length 102.0 mm | In distribution |
| 60-15520 | Diameter: 1.5 Millimeter | In distribution |
| 92-16785 | Diameter: 1.6 Millimeter | In distribution |
| 91-16526 | Diameter: 1.6 Millimeter | In distribution |
| 92-60153 | Diameter: 1.4 Millimeter | In distribution |
| 60-16996 | Length 6.0 mm | In distribution |
| 91-09504 | Length 46.0 mm | In distribution |
| 60-15008 | Length 8.6 mm | In distribution |
| 91-15008 | Length 8.6 mm | In distribution |
| 92-16014 | Length 25.0 mm | In distribution |
| 62-20500 | Length 122.0 mm | In distribution |
| 92-60050 | Length 20.0 mm | In distribution |
| 91-15105 | Diameter: 1.5 Millimeter | In distribution |
| 92-60132 | Length 13.5 mm | In distribution |
| 91-16007 | Diameter: 1.6 Millimeter | In distribution |
| 92-60104 | Length 48.0 mm | In distribution |
| 91-10108 | Length 8.0 mm | In distribution |
| 91-10104 | Diameter: 1.0 Millimeter | In distribution |
| 60-13505 | Length 6.5 mm | In distribution |
| 92-60005 | Length 7.0 mm | In distribution |
| 92-15010 | Length 10.0 mm | In distribution |
| 92-16010 | Length 21.0 mm | In distribution |
| 60-13147 | Length 5.0 mm | In distribution |
| 60-08103 | Diameter: 0.8 Millimeter | In distribution |
| 60-14708 | Diameter: 1.4 Millimeter | In distribution |
| 92-19928 | Length 21.0 mm | In distribution |
| 60-10506 | Diameter: 1.0 Millimeter | In distribution |
| 92-60908 | Length 9.0 mm | In distribution |
| 60-16526 | Length 58.0 mm | In distribution |
| 92-16820 | Length 114.0 mm | In distribution |
| 60-13712 | Diameter: 1.4 Millimeter | In distribution |
| 60-10104 | Diameter: 1.0 Millimeter | In distribution |
| 60-15620 | Diameter: 1.5 Millimeter | In distribution |
| 91-15486 | Length 8.0 mm | In distribution |
| 92-15014 | Length 25.0 mm | In distribution |
| 60-16435 | Length 115.0 mm | In distribution |
| 91-08195 | Diameter: 1.5 Millimeter | In distribution |
| 92-60306 | Length 85.0 mm | In distribution |
| 60-10908 | Length 18.0 mm | In distribution |
| 92-60137 | Length 7.5 mm | In distribution |
| 60-20050 | Length 125.0 mm | In distribution |
| 91-13570 | Diameter: 1.3 Millimeter | In distribution |
| 60-16726 | Length 58.0 mm | In distribution |
| 60-16007 | Length 9.0 mm | In distribution |
| 60-19820 | Length 20.0 mm | In distribution |
| 92-13518 | Length 19.0 mm | In distribution |
| 60-10112 | Diameter: 1.0 Millimeter | In distribution |
| 92-19620 | Diameter: 1.9 Millimeter | In distribution |
| 60-13506 | Diameter: 1.35 Millimeter | In distribution |
| 91-19035 | Diameter: 1.9 Millimeter | In distribution |
| 92-16135 | Length 35.0 mm | In distribution |
| 60-15720 | Length 20.0 mm | In distribution |
| 91-10112 | Length 54.0 mm | In distribution |
| 60-16998 | Diameter: 1.6 Millimeter | In distribution |
| 60-15486 | Length 21.0 mm | In distribution |
| 91-10506 | Length 8.5 mm | In distribution |
| 60-13770 | Length 79.0 mm | In distribution |
| 92-15012 | Diameter: 1.5 Millimeter | In distribution |
| 92-19035 | Length 115.0 mm | In distribution |
| 92-16908 | Length 9.0 mm | In distribution |
| 60-15016 | Diameter: 1.5 Millimeter | In distribution |
| 60-19735 | Length 85.0 mm | In distribution |
| 92-13508 | Length 8.0 mm | In distribution |
| 60-13705 | Length 6.5 mm | In distribution |
| 92-60165 | Length 35.0 mm | In distribution |
| 92-12104 | Diameter: 1.2 Millimeter | In distribution |
| 92-60007 | Length 9.0 mm | In distribution |
| 60-93160 | Length 85.0 mm | In distribution |
| 60-19620 | Length 110.0 mm | In distribution |
| 91-16535 | Length 85.0 mm | In distribution |
| 91-13505 | Length 50.0 mm | In distribution |
| 60-16620 | Length 110.0 mm | In distribution |
| 92-19038 | Length 115.0 mm | In distribution |
| 91-15020 | Diameter: 1.5 Millimeter | In distribution |
| 91-19535 | Length 26.0 mm | In distribution |
| 92-60135 | Length 90.0 mm | In distribution |
| 92-19006 | Length 17.0 mm | In distribution |
| 91-15920 | Length 107.5 mm | In distribution |
| 92-60197 | Diameter: 1.9 Millimeter | In distribution |
| 60-16720 | Diameter: 1.6 Millimeter | In distribution |
| 60-16005 | Length 50.0 mm | In distribution |
| 92-09505 | Diameter: 1.0 Millimeter | In distribution |
| 60-16735 | Length 85.0 mm | In distribution |
| 60-13570 | Diameter: 1.3 Millimeter | In distribution |
| 92-19820 | Length 21.0 mm | In distribution |
| 60-15496 | Length 16.0 mm | In distribution |
| 92-15485 | Diameter: 1.5 Millimeter | In distribution |
| 60-20012 | Diameter: 2.0 Millimeter | In distribution |
| 60-15020 | Length 20.0 mm | In distribution |
| 60-95123 | Diameter: 2.25 Millimeter | In distribution |
| 60-10512 | Length 14.6 mm | In distribution |
| 60-08104 | Diameter: 0.8 Millimeter | In distribution |
| 60-14008 | Length 54.0 mm | In distribution |
| 60-15920 | Length 107.5 mm | In distribution |
| 60-15705 | Diameter: 1.5 Millimeter | In distribution |
| 91-16918 | Length 29.0 mm | In distribution |
| 92-16006 | Diameter: 1.6 Millimeter | In distribution |
| 60-08106 | Diameter: 0.8 Millimeter | In distribution |
| 92-12106 | Length 6.0 mm | In distribution |
| 60-19435 | Diameter: 1.9 Millimeter | In distribution |
| 60-19526 | Length 26.0 mm | In distribution |
| 60-16050 | Length 5.0 mm | In distribution |
| 60-19018 | Length 29.0 mm | In distribution |
| 60-13706 | Length 50.0 mm | In distribution |
| 91-10512 | Diameter: 1.0 Millimeter | In distribution |
| 60-10504 | Length 4.0 mm | In distribution |
| 60-16035 | Diameter: 1.6 Millimeter | In distribution |
| 91-14008 | Length 9.5 mm | In distribution |
| 92-16620 | Length 120.0 mm | In distribution |
| 60-16918 | Length 29.0 mm | In distribution |
| 60-10108 | Diameter: 1.0 Millimeter | In distribution |
| 62-23150 | Length 27.0 mm | In distribution |
| 01-00780 | Length 70.0 mm | In distribution |
| 91-16035 | Length 35.0 mm | In distribution |
| 01-00770 | Diameter: 1.7 Millimeter | In distribution |
| 60-19535 | Diameter: 1.9 Millimeter | In distribution |
| 60-13512 | Diameter: 1.4 Millimeter | In distribution |
| 92-60199 | Length 115.0 mm | In distribution |
| 92-15120 | Length 50.0 mm | In distribution |
| 60-80142 | Length 41.5 mm | In distribution |
| 92-60720 | Diameter: 1.5 Millimeter | In distribution |
| 60-19726 | Diameter: 1.9 Millimeter | In distribution |
| 92-60163 | Diameter: 1.6 Millimeter | In distribution |
| 60-15995 | Diameter: 1.5 Millimeter | In distribution |
| 60-93110 | Diameter: 4.0 Millimeter | In distribution |
| 91-13506 | Length 7.5 mm | In distribution |
| 60-19135 | Diameter: 1.9 Millimeter | In distribution |
| 92-19758 | Diameter: 1.9 Millimeter | In distribution |
| 60-10706 | Length 7.8 mm | In distribution |
| 60-19998 | Length 19.0 mm | In distribution |
| 91-15496 | Diameter: 1.5 Millimeter | In distribution |
| 91-19918 | Diameter: 1.9 Millimeter | In distribution |
| 92-19135 | Length 115.0 mm | In distribution |
| 60-19035 | Length 35.0 mm | In distribution |
| 92-16035 | Length 20.0 mm | In distribution |
| 68-60030 | Length 150.0 mm | In distribution |
| 92-16012 | Length 23.0 mm | In distribution |
| 60-16405 | Length 7.0 mm | In distribution |
| 91-16908 | Diameter: 1.6 Millimeter | In distribution |
| 92-16016 | Length 27.0 mm | In distribution |
| 60-15105 | Diameter: 1.5 Millimeter | In distribution |
| 91-13512 | Diameter: 1.4 Millimeter | In distribution |
| 91-08717 | Diameter: 2.0 Millimeter | In distribution |
| 60-10712 | Length 54.0 mm | In distribution |
| 60-14908 | Diameter: 1.4 Millimeter | In distribution |
| 60-16018 | Diameter: 1.6 Millimeter | In distribution |
| 60-16135 | Diameter: 1.6 Millimeter | In distribution |
| 60-94120 | Diameter: 1.95 Millimeter | In distribution |
| 60-15998 | Length 8.0 mm | In distribution |
| 92-16115 | Length 115.0 mm | In distribution |
| 60-16407 | Length 9.0 mm | In distribution |
| 01-00790 | Length 10.0 mm | In distribution |
| 62-20501 | Length 127.0 mm | In distribution |
| 60-09504 | Length 5.8 mm | In distribution |
| 60-15442 | Length 45.0 mm | Withdrawn |
| 60-10487 | Length 21.0 mm | Withdrawn |
| 92-60507 | Diameter: 1.0 Millimeter | Withdrawn |
| 60-13153 | Diameter: 1.3 Millimeter | Withdrawn |
| 91-08697 | Length 40.0 mm | Withdrawn |
| 60-15120 | Diameter: 1.5 Millimeter | Withdrawn |
| 92-16906 | Diameter: 1.6 Millimeter | Withdrawn |
| 60-15184 | Length 125.0 mm | Withdrawn |
| 60-12206 | Diameter: 1.2 Millimeter | Withdrawn |
| 60-13447 | Length 5.0 mm | Withdrawn |
| 91-18155 | Length 25.0 mm | Withdrawn |
| 60-18182 | Length 25.0 mm | Withdrawn |
| 60-12106 | Length 50.0 mm | Withdrawn |
| 60-15484 | Length 125.0 mm | Withdrawn |
| 92-19906 | Length 7.0 mm | Withdrawn |
| 60-19720 | Length 20.0 mm | Withdrawn |
| 60-27305 | Length 96.0 mm | Withdrawn |
| 01-08719 | Length 76.0 mm | Withdrawn |
| 91-13150 | Diameter: 1.3 Millimeter | Withdrawn |
| 91-18182 | Length 98.0 mm | Withdrawn |
| 60-15182 | Length 85.0 mm | Withdrawn |
| 60-19506 | Length 60.0 mm | Withdrawn |
| 60-08406 | Diameter: 0.8 Millimeter | Withdrawn |
| 60-13105 | Length 22.0 mm | Withdrawn |
| 60-10404 | Length 4.0 mm | Withdrawn |
| 01-08717 | Length 76.0 mm | Withdrawn |
| 01-08697 | Length 40.0 mm | Withdrawn |
| 91-08198 | Length 22.0 mm | Withdrawn |
| 60-07406 | Diameter: 0.7 Millimeter | Withdrawn |
| 01-08199 | Length 7.0 mm | Withdrawn |
| 60-15142 | Length 16.0 mm | Withdrawn |
| 60-13450 | Length 50.0 mm | Withdrawn |
| 92-60410 | Length 85.0 mm | Withdrawn |
| 6514-7-111 | Length 6.0 mm | Withdrawn |
| 60-18155 | Length 58.0 mm | Withdrawn |
| 91-08106 | Length 6.0 mm | Withdrawn |
| 60-12296 | Diameter: 1.2 Millimeter | Withdrawn |
| 60-07106 | Length 6.0 mm | Withdrawn |
| 60-10439 | Length 39.0 mm | Withdrawn |
| 60-15153 | Diameter: 1.5 Millimeter | Withdrawn |
| 60-27105 | Diameter: 2.7 Millimeter | Withdrawn |
| 60-12504 | Diameter: 1.2 Millimeter | Withdrawn |
| 60-15138 | Diameter: 1.5 Millimeter | Withdrawn |
| 60-94500 | Length 42.0 mm | Withdrawn |
| 60-15436 | Length 4.6 mm | Withdrawn |
| 60-18482 | Length 80.0 mm | Withdrawn |
| 60-15440 | Length 20.0 mm | Withdrawn |
| 60-15136 | Length 3.6 mm | Withdrawn |
| 92-60735 | Length 27.0 mm | Withdrawn |
| 91-16820 | Length 21.0 mm | Withdrawn |
| 60-20182 | Length 55.0 mm | Withdrawn |
| 60-20484 | Diameter: 2.0 Millimeter | Withdrawn |
| 60-15140 | Length 44.0 mm | Withdrawn |
| 91-19908 | Length 9.0 mm | Withdrawn |
| 60-20482 | Diameter: 2.0 Millimeter | Withdrawn |
| 91-13147 | Length 47.0 mm | Withdrawn |
| 60-10408 | Diameter: 1.0 Millimeter | Withdrawn |
| 60-10105 | Length 50.0 mm | Withdrawn |
| 60-10412 | Length 38.0 mm | Withdrawn |
| 91-13487 | Length 8.0 mm | Withdrawn |
| 60-14153 | Length 50.0 mm | Withdrawn |
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 |
| 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.