Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K123270
POWEREASE SYSTEM · Medtronic Sofamor Danek USA, Inc. · decided 2013-01-11 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| POWEREASE™ Instruments | 2342425 | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00643169013100 |
| POWEREASE™ Instruments | 2342426 | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00643169013117 |