510(k) K110574 ยท HRS Plate, Fixation, Bone
BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM
| Applicant | Biomet Microfixation, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, May 18, 2011 |
| Received | Mar 1, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110574
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2012 | Biomet Microfixation, Inc. The SternaLock Blu Implant Tray includes plates, screws, screw measuring device, and blades.
The SternaLock Blu Implant Tray would have been found within the following outer containers:
Silver Instr Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.