The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Fixed Bearing Uni Component.
| Device ID | K021621 |
| 510k Number | K021621 |
| Device Name: | FIXED BEARING UNI COMPONENT |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Dalene T Binkly |
| Correspondent | Dalene T Binkly BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-16 |
| Decision Date | 2002-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304180635 | K021621 | 000 |
| 00880304180772 | K021621 | 000 |
| 00880304180789 | K021621 | 000 |
| 00880304180796 | K021621 | 000 |
| 00880304180802 | K021621 | 000 |
| 00880304180819 | K021621 | 000 |
| 00880304180826 | K021621 | 000 |
| 00880304180833 | K021621 | 000 |
| 00880304180840 | K021621 | 000 |
| 00880304180765 | K021621 | 000 |
| 00880304180758 | K021621 | 000 |
| 00880304180741 | K021621 | 000 |
| 00880304180642 | K021621 | 000 |
| 00880304180659 | K021621 | 000 |
| 00880304180666 | K021621 | 000 |
| 00880304180673 | K021621 | 000 |
| 00880304180680 | K021621 | 000 |
| 00880304180697 | K021621 | 000 |
| 00880304180703 | K021621 | 000 |
| 00880304180734 | K021621 | 000 |
| 00880304180857 | K021621 | 000 |
| 00880304180864 | K021621 | 000 |
| 00880304181007 | K021621 | 000 |
| 00880304181038 | K021621 | 000 |
| 00880304181045 | K021621 | 000 |
| 00880304181052 | K021621 | 000 |
| 00880304181069 | K021621 | 000 |
| 00880304181076 | K021621 | 000 |
| 00880304181083 | K021621 | 000 |
| 00880304181090 | K021621 | 000 |
| 00880304180994 | K021621 | 000 |
| 00880304180987 | K021621 | 000 |
| 00880304180970 | K021621 | 000 |
| 00880304180871 | K021621 | 000 |
| 00880304180888 | K021621 | 000 |
| 00880304180895 | K021621 | 000 |
| 00880304180901 | K021621 | 000 |
| 00880304180932 | K021621 | 000 |
| 00880304180949 | K021621 | 000 |
| 00880304180956 | K021621 | 000 |
| 00880304180963 | K021621 | 000 |
| 00880304181106 | K021621 | 000 |