Powerease™ Instruments
TAP 2342425 4.5-5.5MM Self Drilling TAP
3manufacturers in China registered for this device type
36catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Shaanxi (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Shenzhen Launch Electrical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | GWF |
| Device type | Stimulator, Electrical, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1870 |
| 510(k) | K111520 |
| Record published | 2016-04-16 |
| Record revised | 2025-03-21 (version 6) |
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, serial number |
| Distribution end date | 2020-03-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2341426L | 6.5mm | In distribution |
| 2300000LO | In distribution | |
| 2345035L | 3.5mm | In distribution |
| 2341431L | 9.0mm | In distribution |
| 2341421M | 4.0mm | In distribution |
| 2341428S | 7.5mm | In distribution |
| 2342300M | In distribution | |
| G2345030S | 3.0mm | In distribution |
| 2346010 | In distribution | |
| 2345030M | 3.0mm | In distribution |
| 2342425 | D=4.5mm-5.5mm | In distribution |
| 2342280S | In distribution | |
| 2342393M | In distribution | |
| 2343431L | In distribution | |
| 2341427S | 7.0mm | In distribution |
| 2341434L | 10.5mm | In distribution |
| 2341429S | 8.0mm | In distribution |
| 2342300L | In distribution | |
| 2341433L | 10.0mm | In distribution |
| 2341421L | 4.0mm | In distribution |
| 2343429L | In distribution | |
| 2341433S | 10.0mm | In distribution |
| 2342301L | In distribution | |
| 2340000LO | In distribution | |
| 2341423S | 5.0mm | In distribution |
| 2342305S | In distribution | |
| 2342326L | In distribution | |
| 2343435 | 15.0 mm | In distribution |
| 2341420M | 3.75mm | In distribution |
| 2341427M | 7.0mm | In distribution |
| 2340000LO | In distribution | |
| 2341426S | 6.5mm | In distribution |
| 2342281L | In distribution | |
| 2300000 | In distribution | |
| 2342393L | In distribution | |
| 2342375M | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stimulator, Electrical, Evoked Response | Inomed Medizintechnik Gmbh | 170 |
| Alpine BioMed | Alpine Biomed Aps | 132 |
| Natus | Natus Neurology Incorporated | 98 |
| Keypoint | Natus Manufacturing Limited | 44 |
| Stimulator, Electrical, Evoked Response | Nihon Kohden America, Inc. | 41 |
| Stimulator, Electrical, Evoked Response | Nihon Kohden Corp. | 38 |
| Stimulator, Electrical, Evoked Response | Stryker Leibinger Gmbh & Co. KG | 29 |
| Natus | Xltek | 27 |
| Isis | Inomed Medizintechnik Gmbh | 26 |
| Xltek | Xltek | 24 |
| Natus Neurology | Natus Neurology Incorporated | 20 |
| Pulse | Nuvasive, Inc. | 16 |
Showing 12 of 121. All products under Stimulator, Electrical, Evoked Response
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.