The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Titanium Ankle Arthrodesis Nail.
| Device ID | K021786 |
| 510k Number | K021786 |
| Device Name: | TITANIUM ANKLE ARTHRODESIS NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Lonnie Witham |
| Correspondent | Lonnie Witham BIOMET, INC. 56 EAST BELL DR. 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 | 2002-05-30 |
| Decision Date | 2002-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304357266 | K021786 | 000 |
| 00880304357259 | K021786 | 000 |
| 00880304357235 | K021786 | 000 |
| 00880304357211 | K021786 | 000 |
| 00880304357198 | K021786 | 000 |
| 00880304357174 | K021786 | 000 |