510(k) K033838 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
TITANIUM TOGGLE BUTTON(S)
| Applicant | Biomet Manufacturing, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 13, 2004 |
| Received | Dec 10, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033838
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Biomet Sports Medicine Artificial Ligament Fixation Device 15MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 25MM TI NS ToggleLoc (TM) Terminated |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.