510(k) K082175 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION
| Applicant | Bioplate, Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Aug 13, 2008 |
| Received | Aug 1, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082175
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.