The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Mak Oss Knee Femoral Components.
| Device ID | K083779 |
| 510k Number | K083779 |
| Device Name: | MAK OSS KNEE FEMORAL COMPONENTS |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. 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 | 2008-12-19 |
| Decision Date | 2009-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304654105 | K083779 | 000 |
| 00880304653955 | K083779 | 000 |
| 00880304653948 | K083779 | 000 |
| 00880304653931 | K083779 | 000 |
| 00880304653924 | K083779 | 000 |
| 00880304653917 | K083779 | 000 |
| 00880304653900 | K083779 | 000 |
| 00880304653894 | K083779 | 000 |
| 00880304653887 | K083779 | 000 |
| 00880304653870 | K083779 | 000 |
| 00880304653863 | K083779 | 000 |
| 00880304653856 | K083779 | 000 |
| 00880304653962 | K083779 | 000 |
| 00880304653979 | K083779 | 000 |
| 00880304653986 | K083779 | 000 |
| 00880304654099 | K083779 | 000 |
| 00880304654082 | K083779 | 000 |
| 00880304654075 | K083779 | 000 |
| 00880304654068 | K083779 | 000 |
| 00880304654051 | K083779 | 000 |
| 00880304654044 | K083779 | 000 |
| 00880304654037 | K083779 | 000 |
| 00880304654020 | K083779 | 000 |
| 00880304654013 | K083779 | 000 |
| 00880304654006 | K083779 | 000 |
| 00880304653993 | K083779 | 000 |
| 00880304653283 | K083779 | 000 |