The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for X-series Bi-metric Hip Femoral Components.
| Device ID | K020580 |
| 510k Number | K020580 |
| Device Name: | X-SERIES BI-METRIC HIP FEMORAL COMPONENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-21 |
| Decision Date | 2002-03-22 |
| Summary: | summary |