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 |