The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Biomet External Wrist Plate.
| Device ID | K003240 |
| 510k Number | K003240 |
| Device Name: | BIOMET EXTERNAL WRIST PLATE |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Tracy J Bickel |
| Correspondent | Tracy J Bickel BIOMET, INC. 56 EAST BELL DR. 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 | 2000-10-17 |
| Decision Date | 2000-12-29 |