The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Modular Arthrodesis Nail.
| Device ID | K042409 |
| 510k Number | K042409 |
| Device Name: | MODULAR ARTHRODESIS NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Gary Baker |
| Correspondent | Gary Baker BIOMET, INC. 56 EAST BELL DR. 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 | 2004-09-03 |
| Decision Date | 2004-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304083073 | K042409 | 000 |
| 00880304082984 | K042409 | 000 |
| 00880304082991 | K042409 | 000 |
| 00880304083004 | K042409 | 000 |
| 00880304083011 | K042409 | 000 |
| 00880304083028 | K042409 | 000 |
| 00880304083035 | K042409 | 000 |
| 00880304083042 | K042409 | 000 |
| 00880304083059 | K042409 | 000 |
| 00880304083066 | K042409 | 000 |
| 00880304082977 | K042409 | 000 |