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 |