The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Biomet Cobalt-chrome Femoral Components.
| Device ID | K911684 |
| 510k Number | K911684 |
| Device Name: | BIOMET COBALT-CHROME FEMORAL COMPONENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia M Sandborn |
| Correspondent | Patricia M Sandborn BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-16 |
| Decision Date | 1991-06-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304256699 | K911684 | 000 |
| 05019279400768 | K911684 | 000 |
| 05019279400751 | K911684 | 000 |
| 05019279400720 | K911684 | 000 |
| 05019279400676 | K911684 | 000 |
| 00887868308291 | K911684 | 000 |
| 00887868308284 | K911684 | 000 |
| 00887868308277 | K911684 | 000 |
| 00887868308253 | K911684 | 000 |
| 00887868264863 | K911684 | 000 |
| 00887868264849 | K911684 | 000 |
| 00887868264832 | K911684 | 000 |
| 05019279400799 | K911684 | 000 |
| 00880304007208 | K911684 | 000 |
| 00880304007222 | K911684 | 000 |
| 00880304256682 | K911684 | 000 |
| 00880304256668 | K911684 | 000 |
| 00880304256637 | K911684 | 000 |
| 00880304256620 | K911684 | 000 |
| 00880304256521 | K911684 | 000 |
| 00880304256507 | K911684 | 000 |
| 00880304223431 | K911684 | 000 |
| 00880304192133 | K911684 | 000 |
| 00880304192102 | K911684 | 000 |
| 00880304192072 | K911684 | 000 |
| 00880304192058 | K911684 | 000 |
| 00887868264818 | K911684 | 000 |