510(k) K121624 ยท GWO Plate, Cranioplasty, Preformed, Alterable
BIOMET MICROFIXATION NEURO PLATING SYSTEM
| Applicant | Biomet Microfixation, Jacksonville FL, US |
| Decision | Substantially Equivalent, Oct 12, 2012 |
| Received | Jun 1, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121624
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2015 | Biomet Microfixation, LLC Neuro Combo Set Case
The cases hold surgical instrumentation in place during handling and storage. Terminated |
GWO | None listed |
| Aug 6, 2015 | Biomet Microfixation, LLC Thinflap System Case
The cases hold surgical instrumentation in place during handling and storage. Terminated |
GWO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.