510(k) K082757 ยท JEY Plate, Bone
MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM
| Applicant | Bioplate, Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Oct 1, 2008 |
| Received | Sep 19, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082757
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2011 | Bioplate Inc Bioplate Titanium Fixation System, Sterile Kit.
The sterile plate and screw kit configurations for use with the Bioplate Titanium Fixation System are intended for use on non-load bearing fixation, in Terminated |
JEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.