510(k) K874400 ยท DZE Implant, Endosseous, Root-Form
NON-ROTATING GOLD CYLINDER AND SCREW
| Applicant | Implant Innovations International, Inc., West Palm Beach FL, US |
| Decision | Substantially Equivalent, Mar 2, 1988 |
| Received | Oct 28, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K874400
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2010 | Biomet 3i, LLC BIOMET 3i GS300 GOLD SLOTTED SCREW-3mm, STERILE, Rx Only. Made in USA. Lots 868517, 865348, and 868515.
BIOMET 3i, 4555 Riverside Dr., Palm Beach Gardens, FL. Terminated |
DZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.