510(k) K112389 ยท PBF Orthopaedic Surgical Planning And Instrument Guides
SURGICASE CONNECT, SURGICASE GUIDE
| Applicant | Materialise NV, Leuven, BE |
| Decision | Substantially Equivalent, Jul 20, 2012 |
| Received | Aug 18, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112389
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.