The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Nelson Resurfacing Head.
| Device ID | K983452 |
| 510k Number | K983452 |
| Device Name: | NELSON RESURFACING HEAD |
| Classification | Prosthesis, Hip, Femoral, Resurfacing |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Julie K Ryan |
| Correspondent | Julie K Ryan BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KXA |
| CFR Regulation Number | 888.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-30 |
| Decision Date | 1998-12-03 |
| Summary: | summary |