510(k) K130608 ยท HAW Neurological Stereotaxic Instrument
QUADCUT
| Applicant | Medtronic Navigation, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Aug 7, 2013 |
| Received | Mar 7, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130608
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.