510(k) K081475 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]
| Applicant | Medtronic Xomed, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, Oct 17, 2008 |
| Received | May 27, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081475
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 15, 2021 | Medtronic Xomed, Inc. Software 1898072 IPC upgrade v 2.7.3.0, IPC System:
a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC Terminated |
ERL | None listed |
| Oct 21, 2021 | Medtronic Xomed, Inc. Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following produ Open, Classified |
HBE | None listed |
| Jun 28, 2016 | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: ES310-R; Used to dis Terminated |
HBE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.