The following data is part of a premarket notification filed by Biomet Inc with the FDA for Ulna Plating System.
| Device ID | K162424 |
| 510k Number | K162424 |
| Device Name: | Ulna Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | BIOMET INC 56 E BELL DR Warsaw, IN 46582 |
| Contact | Julie Largent |
| Correspondent | Julie Largent BIOMET INC 56 E BELL DR Warsaw, IN 46582 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-30 |
| Decision Date | 2016-10-12 |
| Summary: | summary |