Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K111520
IPC POWEREASE SYSTEM · Medtronic Xomed, Inc. · decided 2011-10-26 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Indigo™ | 31141583 | MEDTRONIC POWERED SURGICAL SOLUTIONS | ERL HBE | 00643169579293 |
| POWEREASE™ Instruments | 2345042L | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00613994917652 |
| IPC™ | 2340000LO | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00643169882829 |
| POWEREASE™ Instruments | 2346030 | MEDTRONIC SOFAMOR DANEK, INC. | HBE | 00613994917713 |
| POWEREASE™ Instruments | 2342306L | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00613994905710 |
| POWEREASE™ Instruments | 2300000 | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00613994448705 |
| Indigo™ | 31131583 | MEDTRONIC POWERED SURGICAL SOLUTIONS | ERL HBE | 00643169579224 |
| POWEREASE™ Instruments | 2342393M | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00613994649683 |
| POWEREASE™ Instruments | 2341431L | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00613994649638 |
| Powerease® | 2300000LO | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00643169882812 |
| POWEREASE™ Instruments | 2341428M | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00613994650016 |
| POWEREASE™ Instruments | 2342401 | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00643169007598 |
| POWEREASE™ Instruments | 2342280L | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00613994649751 |
| POWEREASE™ Instruments | 2342281M | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00613994905604 |
| POWEREASE™ Instruments | 2341420S | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00613994649942 |
| POWEREASE™ Instruments | 2341433M | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00613994649560 |
| POWEREASE™ Instruments | G2345030M | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00613994952066 |
| POWEREASE™ Instruments | 2341429S | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00613994649973 |
| POWEREASE™ Instruments | 2345042S | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00613994917638 |
| POWEREASE™ Instruments | 2345035L | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00613994917621 |
| POWEREASE™ Instruments | 2344000 | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00613994907592 |
| POWEREASE™ Instruments | 2342301L | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00613994905659 |
| POWEREASE™ Instruments | 2342281S | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00613994905611 |
| POWEREASE™ Instruments | 2343431S | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00613994905574 |
| POWEREASE™ Instruments | 2341428L | MEDTRONIC SOFAMOR DANEK, INC. | GWF HBE HWE | 00613994650023 |