The following data is part of a premarket notification filed by Biomet Trauma with the FDA for Biomet Variable Locking Plate System.
| Device ID | K071325 |
| 510k Number | K071325 |
| Device Name: | BIOMET VARIABLE LOCKING PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | BIOMET TRAUMA P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Susan Alexander |
| Correspondent | Susan Alexander BIOMET TRAUMA P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-10 |
| Decision Date | 2007-07-26 |
| Summary: | summary |