510(k) K013050 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
| Applicant | Bioplate, Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Dec 10, 2001 |
| Received | Sep 11, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013050
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.