510(k) K140622 ยท HRS Plate, Fixation, Bone
DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, May 13, 2014 |
| Received | Mar 11, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140622
| 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.