510(k) K133082 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
| Applicant | Osteosymbionics, LLC, Cleveland OH, US |
| Decision | Substantially Equivalent, May 20, 2014 |
| Received | Sep 30, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133082
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.