The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Rx90 Femoral Component.
Device ID | K942028 |
510k Number | K942028 |
Device Name: | RX90 FEMORAL COMPONENT |
Classification | Prosthesis, Hip, Femoral Component, Cemented, Metal |
Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
Contact | Patricia S Beres |
Correspondent | Patricia S Beres BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
Product Code | JDG |
CFR Regulation Number | 888.3360 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-26 |
Decision Date | 1994-09-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00880304257283 | K942028 | 000 |
00880304226050 | K942028 | 000 |
00880304226043 | K942028 | 000 |
00880304226036 | K942028 | 000 |
00880304226029 | K942028 | 000 |
00880304226012 | K942028 | 000 |
00880304225992 | K942028 | 000 |
00880304225985 | K942028 | 000 |
00880304225961 | K942028 | 000 |
00880304008397 | K942028 | 000 |
00880304007666 | K942028 | 000 |
00880304001152 | K942028 | 000 |
00887868163517 | K942028 | 000 |
00887868163500 | K942028 | 000 |
00887868163494 | K942028 | 000 |
00887868163487 | K942028 | 000 |
00887868163470 | K942028 | 000 |
00880304226067 | K942028 | 000 |
00880304226074 | K942028 | 000 |
00880304257276 | K942028 | 000 |
00880304257269 | K942028 | 000 |
00880304257252 | K942028 | 000 |
00880304257245 | K942028 | 000 |
00880304236905 | K942028 | 000 |
00880304236899 | K942028 | 000 |
00880304236875 | K942028 | 000 |
00880304236851 | K942028 | 000 |
00880304236844 | K942028 | 000 |
00880304236790 | K942028 | 000 |
00880304236769 | K942028 | 000 |
00880304226142 | K942028 | 000 |
00880304226135 | K942028 | 000 |
00880304226128 | K942028 | 000 |
00880304226104 | K942028 | 000 |
00880304226098 | K942028 | 000 |
00880304873810 | K942028 | 000 |