The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Titanium Toggle Button(s).
| Device ID | K033838 |
| 510k Number | K033838 |
| Device Name: | TITANIUM TOGGLE BUTTON(S) |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Tracy J Bickel |
| Correspondent | Tracy J Bickel BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-10 |
| Decision Date | 2004-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304469471 | K033838 | 000 |
| 00880304453272 | K033838 | 000 |
| 00880304453289 | K033838 | 000 |
| 00880304453296 | K033838 | 000 |
| 00880304453302 | K033838 | 000 |
| 00880304453319 | K033838 | 000 |
| 00880304453326 | K033838 | 000 |
| 00880304453333 | K033838 | 000 |
| 00880304453364 | K033838 | 000 |
| 00880304464223 | K033838 | 000 |
| 00880304464858 | K033838 | 000 |
| 00880304453265 | K033838 | 000 |