510(k) K854886 ยท JEY Plate, Bone
WUERZBURG TITANIUM MINI BONE PLATES & BONE SCREWS
| Applicant | Walter Lorenz Surgical, Inc., Rockville MD, US |
| Decision | Substantially Equivalent, Jan 21, 1986 |
| Received | Dec 6, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854886
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2010 | Biomet Microfixation, Inc. 2.0/1.0 4 hole long plate (titanium plate ).Lot 120150.
Product labeling reads:
(1. ) REF: 01-9205, Lot 999999, " 2.0MM" SYSTEM PLATE 4 HOLE PLATE, STRAIGHT, LONG.
(2.) QTY 00001, CE 0086, *** Terminated |
JEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.