510(k) K112812 ยท GWO Plate, Cranioplasty, Preformed, Alterable
LEFORTE NEURO SYSTEM BONE PLATE
| Applicant | Jeil Medical Corporation, Norcross GA, US |
| Decision | Substantially Equivalent, Feb 22, 2012 |
| Received | Sep 27, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112812
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.