The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Affixus Tibial Nailing System.
| Device ID | K150867 |
| 510k Number | K150867 |
| Device Name: | Affixus Tibial Nailing System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | BIOMET, INC. 56 EAST BELL DRIVE Warsaw, IN 46581 |
| Contact | Suzana Otano |
| Correspondent | Suzana Otano BIOMET, INC. 56 EAST BELL DRIVE Warsaw, IN 46581 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-01 |
| Decision Date | 2015-06-10 |
| Summary: | summary |