2.0MM System
TW Drill 1.5X50MM 7MM STP W/NT
3manufacturers in China registered for this device type
23catalogue 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 | Biomet Microfixation, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K062842 |
| Record published | 2014-09-17 |
| Record revised | 2025-05-30 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2025-07-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-9180 | In distribution | |
| 01-9197 | In distribution | |
| 01-9203 | In distribution | |
| 01-9196 | In distribution | |
| 01-9199 | In distribution | |
| 01-9181 | In distribution | |
| SP-1992 | In distribution | |
| 31-2050 | In distribution | |
| 01-9193 | In distribution | |
| SP-1993 | In distribution | |
| 01-9200 | In distribution | |
| 01-9192 | In distribution | |
| SP-2421 | In distribution | |
| 01-9198 | In distribution | |
| 01-9176 | In distribution | |
| 01-9195 | In distribution | |
| 01-9202 | In distribution | |
| 31-2051 | In distribution | |
| 31-2050 | Withdrawn | |
| SP-2421 | Withdrawn | |
| 31-2051 | Withdrawn | |
| SP-2640 | Withdrawn | |
| SP-2640 | Withdrawn |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 |
| 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 |
Showing 12 of 269. All products under Drills, Burrs, Trephines & Accessories (Simple, Powered)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223199 | 2022-11-15 |
| K213208 | 2021-12-23 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biomet Microfixation | 510(k) number | 2009-11-06 | Not classified | Process change control | The Twist Drill 1.1x50mm, 3.5mm stop, with J notch Lots #’s 537407, 536306, and 535933 which were packaged and shipped without the instructions for use (IFU). | 283 pieces | 2010-03-02 |
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.