The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Ha X-series Bi-metric Hip Femoral Components.
| Device ID | K023409 |
| 510k Number | K023409 |
| Device Name: | HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 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 | 2002-10-10 |
| Decision Date | 2002-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304183155 | K023409 | 000 |
| 00880304182981 | K023409 | 000 |
| 00880304182974 | K023409 | 000 |
| 00880304182967 | K023409 | 000 |
| 00880304182950 | K023409 | 000 |
| 00880304182943 | K023409 | 000 |
| 00880304182936 | K023409 | 000 |
| 00880304182929 | K023409 | 000 |
| 00880304182912 | K023409 | 000 |
| 00880304182905 | K023409 | 000 |
| 00880304182899 | K023409 | 000 |
| 00880304182882 | K023409 | 000 |
| 00880304182875 | K023409 | 000 |
| 00880304182998 | K023409 | 000 |
| 00880304183001 | K023409 | 000 |
| 00880304183025 | K023409 | 000 |
| 00880304183148 | K023409 | 000 |
| 00880304183131 | K023409 | 000 |
| 00880304183124 | K023409 | 000 |
| 00880304183117 | K023409 | 000 |
| 00880304183100 | K023409 | 000 |
| 00880304183094 | K023409 | 000 |
| 00880304183087 | K023409 | 000 |
| 00880304183070 | K023409 | 000 |
| 00880304183063 | K023409 | 000 |
| 00880304183056 | K023409 | 000 |
| 00880304183049 | K023409 | 000 |
| 00880304183032 | K023409 | 000 |
| 00880304182868 | K023409 | 000 |