510(k) K112595 ยท KWP Appliance, Fixation, Spinal Interlaminal
COFLEX-F
| Applicant | Paradigm Spine, LLC, New York NY, US |
| Decision | Substantially Equivalent, Feb 13, 2012 |
| Received | Sep 7, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112595
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.