The following data is part of a premarket notification filed by Biomet Trauma with the FDA for Biomet Phoenix Ankle Nail And Ankle Arthrodesis Nail.
| Device ID | K091976 |
| 510k Number | K091976 |
| Device Name: | BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | BIOMET TRAUMA 100 INTERPACE PARKWAY Parsippany, NJ 07054 |
| Contact | Margaret Crowe |
| Correspondent | Margaret Crowe BIOMET TRAUMA 100 INTERPACE PARKWAY Parsippany, NJ 07054 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-01 |
| Decision Date | 2009-08-17 |
| Summary: | summary |