510(k) K132704 ยท LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW
| Applicant | Biomet, Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 9, 2013 |
| Received | Aug 29, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132704
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2016 | Biomet, Inc. Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation
The Cross lock DVR ePAK Volar Rim Plates system is intended for Terminated |
LXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.