The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for X-series Integral Lateralized Hip Components.
| Device ID | K030501 |
| 510k Number | K030501 |
| Device Name: | X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET, INC. 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 | 2003-02-19 |
| Decision Date | 2003-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304182554 | K030501 | 000 |
| 00880304182257 | K030501 | 000 |
| 00880304182240 | K030501 | 000 |
| 00880304182233 | K030501 | 000 |
| 00880304182226 | K030501 | 000 |
| 00880304182219 | K030501 | 000 |
| 00880304182202 | K030501 | 000 |
| 00880304182196 | K030501 | 000 |
| 00880304182189 | K030501 | 000 |
| 00880304182172 | K030501 | 000 |
| 00880304182165 | K030501 | 000 |
| 00880304182158 | K030501 | 000 |
| 00880304182141 | K030501 | 000 |
| 00880304182264 | K030501 | 000 |
| 00880304182417 | K030501 | 000 |
| 00880304182424 | K030501 | 000 |
| 00880304182547 | K030501 | 000 |
| 00880304182530 | K030501 | 000 |
| 00880304182523 | K030501 | 000 |
| 00880304182516 | K030501 | 000 |
| 00880304182509 | K030501 | 000 |
| 00880304182493 | K030501 | 000 |
| 00880304182486 | K030501 | 000 |
| 00880304182479 | K030501 | 000 |
| 00880304182462 | K030501 | 000 |
| 00880304182455 | K030501 | 000 |
| 00880304182448 | K030501 | 000 |
| 00880304182431 | K030501 | 000 |
| 00880304182134 | K030501 | 000 |