The following data is part of a premarket notification filed by Biomet with the FDA for Distal Radius Volar Rim Plate Standard, Distal Radius Volar Rim Plate Narrow.
| Device ID | K132704 |
| 510k Number | K132704 |
| Device Name: | DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | BIOMET 56 EAST BELL DR. P.O BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Suzana Otano |
| Correspondent | Suzana Otano BIOMET 56 EAST BELL DR. P.O BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-29 |
| Decision Date | 2013-10-09 |
| Summary: | summary |