The following data is part of a premarket notification filed by Biomet Trauma with the FDA for Biomet Phoenix Ankle Nail System.
| Device ID | K081243 |
| 510k Number | K081243 |
| Device Name: | BIOMET PHOENIX ANKLE NAIL SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | BIOMET TRAUMA P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Susan Alexander |
| Correspondent | Susan Alexander BIOMET TRAUMA 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 | 2008-05-01 |
| Decision Date | 2008-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868151279 | K081243 | 000 |
| 00887868093586 | K081243 | 000 |
| 00887868093579 | K081243 | 000 |
| 00887868093562 | K081243 | 000 |
| 00887868093555 | K081243 | 000 |
| 00887868093548 | K081243 | 000 |
| 00887868093531 | K081243 | 000 |
| 00887868093524 | K081243 | 000 |
| 00887868093517 | K081243 | 000 |
| 00887868093500 | K081243 | 000 |
| 00887868093494 | K081243 | 000 |
| 00887868093593 | K081243 | 000 |
| 00887868093609 | K081243 | 000 |
| 00887868093616 | K081243 | 000 |
| 00887868151262 | K081243 | 000 |
| 00887868093708 | K081243 | 000 |
| 00887868093692 | K081243 | 000 |
| 00887868093685 | K081243 | 000 |
| 00887868093678 | K081243 | 000 |
| 00887868093661 | K081243 | 000 |
| 00887868093654 | K081243 | 000 |
| 00887868093647 | K081243 | 000 |
| 00887868093630 | K081243 | 000 |
| 00887868093623 | K081243 | 000 |
| 00887868093180 | K081243 | 000 |