510(k) K153302 ยท PEK Spinous Process Plate
coflex-IF
| Applicant | Paradigm Spine, LLC, New York NY, US |
| Decision | Substantially Equivalent, Sep 8, 2016 |
| Received | Nov 13, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153302
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.