510(k) K143377 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
PedFuse Pedicle Screw System
| Applicant | Spinefrontier, Inc., Beverly MA, US |
| Decision | Substantially Equivalent, Feb 12, 2015 |
| Received | Nov 25, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K143377
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.