510(k) K140715 ยท PEK Spinous Process Plate
ZIP MIS INTERSPINOUS FUSION SYSTEM
| Applicant | Aurora Spine, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Apr 17, 2014 |
| Received | Mar 21, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140715
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.