The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Brooker Tibia Nails.
| Device ID | K002057 |
| 510k Number | K002057 |
| Device Name: | BROOKER TIBIA NAILS |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-06 |
| Decision Date | 2000-10-04 |