510(k) K133939 ยท HRS Plate, Fixation, Bone
MODIFIED DISTAL RADIUS PLATING SYSTEM
| Applicant | Biomet, Warsaw IN, US |
| Decision | Substantially Equivalent, Apr 1, 2014 |
| Received | Dec 23, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133939
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2022 | Biomet, Inc. BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [Item # 1318-12-176, DVR CROSSLOCK EXTRA EXTRA LONG PLATE RIGHT]. Terminated |
JDR | None listed |
| 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.