The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for X-series Integral Rpp Femoral Components.
| Device ID | K042029 |
| 510k Number | K042029 |
| Device Name: | X-SERIES INTEGRAL RPP FEMORAL COMPONENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET, INC. 56 EAST BELL DR. 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 | 2004-07-28 |
| Decision Date | 2004-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304650503 | K042029 | 000 |
| 00880304650374 | K042029 | 000 |
| 00880304650381 | K042029 | 000 |
| 00880304650398 | K042029 | 000 |
| 00880304650404 | K042029 | 000 |
| 00880304650411 | K042029 | 000 |
| 00880304650428 | K042029 | 000 |
| 00880304650435 | K042029 | 000 |
| 00880304650442 | K042029 | 000 |
| 00880304650459 | K042029 | 000 |
| 00880304650466 | K042029 | 000 |
| 00880304650473 | K042029 | 000 |
| 00880304650480 | K042029 | 000 |
| 00880304650497 | K042029 | 000 |
| 00880304650367 | K042029 | 000 |