510(k) K111520 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
IPC POWEREASE SYSTEM
| Applicant | Medtronic Xomed, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, Oct 26, 2011 |
| Received | Jun 2, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111520
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2025 | Medtronic Xomed, Inc. IPC Powerease System REF 2300000
UDI-DI:
00613994448705
00643169406834.
The IPC POWEREASE System is indicated for drilling, tapping, and driving
screws and working end attachments during spinal surge Open, Classified |
HBE | None listed |
| Jan 12, 2015 | Medtronic Sofamor Danek USA Inc POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent. Terminated |
HWE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.