Powerease™ Instruments
Tapper 2341421S 4MM TC OG NON Cann S
3manufacturers in China registered for this device type
36catalogue 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 | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | HBE |
| Device type | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4310 |
| 510(k) | K111520 |
| Record published | 2016-04-16 |
| Record revised | 2018-10-05 (version 5) |
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 |
| Sizes | Outer diameter 4.2 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2342301M | In distribution | |
| 2341424M | 5.5mm | In distribution |
| 2341425L | 6.0mm | In distribution |
| 2345035S | 3.5mm | In distribution |
| 2342281S | In distribution | |
| 2346013 | In distribution | |
| 2342306L | In distribution | |
| 2342393S | In distribution | |
| 2342393M | In distribution | |
| 2342326M | In distribution | |
| 2341421S | 4.0mm | In distribution |
| 2342306S | In distribution | |
| 2346030 | In distribution | |
| 2341429M | 8.0mm | In distribution |
| 2343431M | In distribution | |
| 2341433M | 10.0mm | In distribution |
| 2341424S | 5.5mm | In distribution |
| 2343426M | In distribution | |
| 2343422L | In distribution | |
| G2345042S | Outer Diameter 4.2 mm | In distribution |
| G2345042L | 4.2mm | In distribution |
| 2343435 | In distribution | |
| 2343431S | In distribution | |
| 2343422S | In distribution | |
| G2345035L | 3.5mm | In distribution |
| 2343426L | In distribution | |
| 2341430S | 8.5mm | In distribution |
| 2342375L | In distribution | |
| 2345042S | 4.2mm | In distribution |
| 2341422L | 4.5mm | In distribution |
| 2341427L | 7.0mm | In distribution |
| 2342301S | In distribution | |
| G2345030M | 3.0mm | In distribution |
| 2341422S | 4.5mm | In distribution |
| 2341432S | 9.5mm | In distribution |
| 2342305M | 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 |
| 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)
Recalls Naming This Product
2 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 | 2025-07-17 | Class II | Process change control | Due to out of the box wobble of the driver. | 214 | |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2014-12-03 | Class II | Process design | The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw. | 24 units | 2015-09-24 |
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.