The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Total Toe System.
| Device ID | K920446 |
| 510k Number | K920446 |
| Device Name: | TOTAL TOE SYSTEM |
| Classification | Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained |
| Applicant | BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Product Code | LZJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-04 |
| Decision Date | 1993-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304217003 | K920446 | 000 |
| 00880304216914 | K920446 | 000 |
| 00880304216907 | K920446 | 000 |
| 00880304216860 | K920446 | 000 |