The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Segmental Distal Femoral Components And Proximal Femoral Bodies With A Compress Female Taper.
| Device ID | K080330 |
| 510k Number | K080330 |
| Device Name: | SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-06 |
| Decision Date | 2008-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304539228 | K080330 | 000 |
| 00880304473669 | K080330 | 000 |
| 00880304473652 | K080330 | 000 |
| 00880304473645 | K080330 | 000 |
| 00880304473638 | K080330 | 000 |
| 00880304473607 | K080330 | 000 |
| 00880304471139 | K080330 | 000 |
| 00880304471122 | K080330 | 000 |
| 00880304061248 | K080330 | 000 |
| 00880304060241 | K080330 | 000 |
| 00880304473676 | K080330 | 000 |
| 00880304475717 | K080330 | 000 |
| 00880304505094 | K080330 | 000 |
| 00880304502062 | K080330 | 000 |
| 00880304500525 | K080330 | 000 |
| 00880304500518 | K080330 | 000 |
| 00880304479333 | K080330 | 000 |
| 00880304479319 | K080330 | 000 |
| 00880304479302 | K080330 | 000 |
| 00880304475908 | K080330 | 000 |
| 00880304475724 | K080330 | 000 |
| 00887868489372 | K080330 | 000 |