The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Im Total Femur.
| Device ID | K033871 |
| 510k Number | K033871 |
| Device Name: | IM TOTAL FEMUR |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Product Code | JDI |
| Subsequent Product Code | JWH |
| Subsequent Product Code | KRO |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-12 |
| Decision Date | 2004-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304240216 | K033871 | 000 |
| 00880304025141 | K033871 | 000 |
| 00880304025134 | K033871 | 000 |
| 00880304025127 | K033871 | 000 |
| 00880304021617 | K033871 | 000 |
| 00880304021600 | K033871 | 000 |
| 00880304021594 | K033871 | 000 |
| 00880304021587 | K033871 | 000 |
| 00880304021570 | K033871 | 000 |
| 00880304021563 | K033871 | 000 |
| 00880304025158 | K033871 | 000 |
| 00880304240117 | K033871 | 000 |
| 00880304240209 | K033871 | 000 |
| 00880304240193 | K033871 | 000 |
| 00880304240186 | K033871 | 000 |
| 00880304240179 | K033871 | 000 |
| 00880304240162 | K033871 | 000 |
| 00880304240155 | K033871 | 000 |
| 00880304240148 | K033871 | 000 |
| 00880304240131 | K033871 | 000 |
| 00880304240124 | K033871 | 000 |
| 00880304021556 | K033871 | 000 |