The following data is part of a premarket notification filed by Biomet Inc. with the FDA for Affixus Hip Fracture Nail.
| Device ID | K183162 |
| 510k Number | K183162 |
| Device Name: | Affixus Hip Fracture Nail |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Biomet Inc. 56 East Bell Drive Warsaw, IN 46582 |
| Contact | Dhaval Saraiya |
| Correspondent | Dhaval Saraiya Biomet Inc. 56 East Bell Drive Warsaw, IN 46582 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-15 |
| Decision Date | 2018-12-14 |
| Summary: | summary |